• FDA ABILIFY MAINTENA KIT NDA 202971 approval records — 41 FDA documents, 1,513 pages
1 1

FDA 510(k) K071545, Z-800 VOLUMETRIC INFUSION PUMP, by Zyno Medical, LLC

FDA 510(k) K071545, Z-800 VOLUMETRIC INFUSION PUMP, by Zyno Medical, LLC

$2,672.03 USD
$2,672.03 USD
Sale Sold out

FDA 510(k) records for Z-800 VOLUMETRIC INFUSION PUMP (K071545), submitted by Zyno Medical, LLC.

  • 510(k) Number: K071545
  • Applicant: Zyno Medical, LLC
  • Decision Date: 10/31/2007
  • Decision: Substantially Equivalent (SESE)
  • Product Code: FRN FRN
  • Review Panel: General Hospital
  • Total PDF Pages: 1608
  • Fully Redacted Pages: 31
  • Usable Pages: 1577

Sections Included

  • Administrative / Introductory Materials: pages 1-9; 0.0% redacted (Unredacted)
  • Indications for Use: pages 10-34; 0.0% redacted (Unredacted)
  • Biocompatibility: pages 35-36; 0.0% redacted (Unredacted)
  • Substantial Equivalence: pages 37-67; 0.0% redacted (Unredacted)
  • Indications for Use: pages 68; 0.0% redacted (Unredacted)
  • Biocompatibility: pages 69; 0.0% redacted (Unredacted)
  • Substantial Equivalence: pages 70-122; 0.0% redacted (Unredacted)
  • Intended Use: pages 123-234; 1.8% redacted (Minimal Redaction)
  • 510(k) Summary: pages 235-259; 0.0% redacted (Unredacted)
  • Indications for Use: pages 260-274; 6.7% redacted (Minimal Redaction)
  • Device Description: pages 275-331; 0.0% redacted (Unredacted)
  • Standards: pages 332-339; 0.0% redacted (Unredacted)
  • Labeling: pages 340-362; 4.3% redacted (Minimal Redaction)
  • Intended Use: pages 363-394; 0.0% redacted (Unredacted)
  • Standards: pages 395-396; 0.0% redacted (Unredacted)
  • Electrical Safety / EMC: pages 397-402; 0.0% redacted (Unredacted)
  • Software: pages 403-865; 3.5% redacted (Minimal Redaction)
  • Indications for Use: pages 866-896; 6.5% redacted (Minimal Redaction)
  • Device Description: pages 897-953; 0.0% redacted (Unredacted)
  • Standards: pages 954-961; 0.0% redacted (Unredacted)
  • Labeling: pages 962-972; 0.0% redacted (Unredacted)
  • Intended Use: pages 973-1340; 1.1% redacted (Minimal Redaction)
  • Standards: pages 1341-1586; 1.2% redacted (Minimal Redaction)
  • Labeling: pages 1587-1608; 9.1% redacted (Minimal 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.

View full details