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FDA 510(k) K945120, THYMATRON 2000 ELECTROCONVULSIVE SYSTEM, by Somatics, Inc.

FDA 510(k) K945120, THYMATRON 2000 ELECTROCONVULSIVE SYSTEM, by Somatics, Inc.

$89.00 USD
$89.00 USD
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  • 510(k) Number: K945120
  • Applicant: Somatics, Inc.
  • Decision Date: 10/26/1995
  • Decision: Substantially Equivalent (SESE)
  • Product Code: QGH QGH
  • Review Panel: Neurology
  • Total PDF Pages: 563
  • Fully Redacted Pages: 256
  • Usable Pages: 307

Sections Included

  • Administrative / Introductory Materials: pages 1-9; 0.0% redacted (Unredacted)
  • CDRH Premarket Review Submission Cover Sheet: pages 10; 0.0% redacted (Unredacted)
  • Sterilization: pages 11; 0.0% redacted (Unredacted)
  • 510(k) Statement: pages 12-13; 0.0% redacted (Unredacted)
  • Standards: pages 14; 0.0% redacted (Unredacted)
  • Indications for Use: pages 15-16; 0.0% redacted (Unredacted)
  • Device Description: pages 17-23; 71.4% redacted (Heavy Redaction)
  • Labeling: pages 24-27; 0.0% redacted (Unredacted)
  • Biocompatibility: pages 28-29; 100.0% redacted (Fully Redacted)
  • Software: pages 30-35; 50.0% redacted (Heavy Redaction)
  • Electrical Safety / EMC: pages 36-46; 18.2% redacted (Moderate Redaction)
  • Intended Use: pages 47-117; 0.0% redacted (Unredacted)
  • Clinical Testing: pages 118-351; 91.9% redacted (Heavy Redaction)
  • Labeling: pages 352-563; 13.7% redacted (Moderate 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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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