FDA 510(k), K083903, 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200

FDA 510(k), K083903, 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200

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510(K) Number: K083903
Device Name: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200
Manufacturer:
Device Classification Name: Stethoscope, Electronic
Regulation Number: 870.1875
Classification Product Code: DQD
Date Received: 12/29/2008
Decision Date: 07/15/2009
Regulation Medical Specialty: Cardiovascular

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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