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FDA 510(k) K150685, Skynector CPAP Mask, by Sky Wise Medical Instrument (Shen Zhen) Co., Ltd.

FDA 510(k) K150685, Skynector CPAP Mask, by Sky Wise Medical Instrument (Shen Zhen) Co., Ltd.

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510(K) Number: K150685
Device Name: Skynector CPAP Mask
Manufacturer: Sky Wise Medical Instrument (Shen Zhen) Co., Ltd.
Device Classification Name: Ventilator, Non-Continuous (Respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 03/17/2015
Decision Date: 08/24/2015
Regulation Medical Specialty: Anesthesiology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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