FDA 510(k), K112822, SLEEPSTRIP II

FDA 510(k), K112822, SLEEPSTRIP II

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510(K) Number: K112822
Device Name: SLEEPSTRIP II
Manufacturer: S.L.P LTD.
Device Classification Name: Ventilatory Effort Recorder
Regulation Number: 868.2375
Classification Product Code: MNR
Date Received: 09/28/2011
Decision Date: 12/27/2011
Regulation Medical Specialty: Anesthesiology

Total pages: 242
Fully redacted pages: 161
Content pages: 81

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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