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FDA 510(k), K062291, VPAP MALIBU WITH H2I
FDA 510(k), K062291, VPAP MALIBU WITH H2I
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510(K) Number: K062291
Device Name: VPAP MALIBU WITH H2I
Manufacturer: RESMED LTD.
Device Classification Name: ventilator, non-continuous (respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 08/07/2006
Decision Date: 09/08/2006
Regulation Medical Specialty: Anesthesiology
Device Name: VPAP MALIBU WITH H2I
Manufacturer: RESMED LTD.
Device Classification Name: ventilator, non-continuous (respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 08/07/2006
Decision Date: 09/08/2006
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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