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FDA 510(k), K100011, FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM
FDA 510(k), K100011, FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM
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510(K) Number: K100011
Device Name: FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM
Manufacturer: FISHER & PAYKEL HEALTHCARE, LTD.
Device Classification Name: ventilator, non-continuous (respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 01/04/2010
Decision Date: 10/08/2010
Regulation Medical Specialty: Anesthesiology
Device Name: FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM
Manufacturer: FISHER & PAYKEL HEALTHCARE, LTD.
Device Classification Name: ventilator, non-continuous (respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 01/04/2010
Decision Date: 10/08/2010
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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