FDA 510(k), K160016, Steth IO

FDA 510(k), K160016, Steth IO

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510(K) Number: K160016
Device Name: Steth IO
Manufacturer: STRATOSCIENTIFIC, INC.
Device Classification Name: Stethoscope, Electronic
Regulation Number: 870.1875
Classification Product Code: DQD
Date Received: 01/05/2016
Decision Date: 07/15/2016
Regulation Medical Specialty: Cardiovascular

Total pages: 6
Fully redacted pages: 1
Content pages: 5

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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