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FDA 510(k) K124018, AMIA AUTOMATED PD SYSTEM, by Deka Research & Development Corp.

FDA 510(k) K124018, AMIA AUTOMATED PD SYSTEM, by Deka Research & Development Corp.

$89.00 USD
$89.00 USD
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510(K) Number: K124018
Device Name: AMIA AUTOMATED PD SYSTEM
Manufacturer: Deka Research & Development Corp.
Device Classification Name: System, Peritoneal, Automatic Delivery
Regulation Number: FKX
Classification Product Code: KXA
Date Received: 12/27/2012
Decision Date: 06/14/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology

  • Total PDF Pages: 5123
  • Fully Redacted Pages: 3626
  • Usable Pages: 1497

Sections Included

  • Administrative / Introductory Materials: pages 1-2561; 70.6% redacted (Heavy Redaction)
  • Software: pages 2562-2859; 84.6% redacted (Heavy Redaction)
  • Cover Letter: pages 2860-2862; 33.3% redacted (Moderate Redaction)
  • 510(k) Cover Sheet: pages 2863-2866; 0.0% redacted (Unredacted)
  • Device Description: pages 2867-2880; 0.0% redacted (Unredacted)
  • 510(k) Cover Sheet: pages 2881; 0.0% redacted (Unredacted)
  • CDRH Premarket Review Submission Cover Sheet: pages 2882-2883; 0.0% redacted (Unredacted)
  • 510(k) Statement: pages 2884; 0.0% redacted (Unredacted)
  • CDRH Premarket Review Submission Cover Sheet: pages 2885-2888; 0.0% redacted (Unredacted)
  • Indications for Use: pages 2889; 0.0% redacted (Unredacted)
  • 510(k) Summary: pages 2890-2891; 0.0% redacted (Unredacted)
  • Performance Testing: pages 2892-2893; 0.0% redacted (Unredacted)
  • Truthful and Accuracy Statement: pages 2894-2897; 0.0% redacted (Unredacted)
  • 510(k) Summary: pages 2898-2900; 0.0% redacted (Unredacted)
  • Indications for Use: pages 2901-2902; 0.0% redacted (Unredacted)
  • Labeling: pages 2903; 0.0% redacted (Unredacted)
  • Performance Testing: pages 2904-2905; 0.0% redacted (Unredacted)
  • Device Description: pages 2906-2973; 41.2% redacted (Heavy Redaction)
  • Labeling: pages 2974-2984; 9.1% redacted (Minimal Redaction)
  • Device Description: pages 2985; 0.0% redacted (Unredacted)
  • Indications for Use: pages 2986-2996; 9.1% redacted (Minimal Redaction)
  • Risk Analysis: pages 2997-3015; 47.4% redacted (Heavy Redaction)
  • Labeling: pages 3016-3100; 15.3% redacted (Moderate Redaction)
  • Cover Letter: pages 3101-3633; 31.5% redacted (Moderate Redaction)
  • Indications for Use: pages 3634-3820; 87.7% redacted (Heavy Redaction)
  • Cover Letter: pages 3821-3970; 88.7% redacted (Heavy Redaction)
  • Software: pages 3971-4195; 96.4% redacted (Heavy Redaction)
  • Cover Letter: pages 4196-4214; 57.9% redacted (Heavy Redaction)
  • Labeling: pages 4215-4798; 92.0% redacted (Heavy Redaction)
  • Indications for Use: pages 4799-4976; 94.9% redacted (Heavy Redaction)
  • Device Description: pages 4977-5089; 82.3% redacted (Heavy Redaction)
  • 510(k) Summary: pages 5090; 0.0% redacted (Unredacted)
  • Performance Testing: pages 5091-5094; 0.0% redacted (Unredacted)
  • Indications for Use: pages 5095-5123; 72.4% redacted (Heavy Redaction)

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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