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FDA 510(k), K150111, Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
FDA 510(k), K150111, Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
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510(K) Number: K150111
Device Name: Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
Manufacturer: APEX MEDICAL CORP.
Device Classification Name: ventilator, non-continuous (respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 01/20/2015
Decision Date: 09/15/2015
Regulation Medical Specialty: Anesthesiology
Device Name: Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
Manufacturer: APEX MEDICAL CORP.
Device Classification Name: ventilator, non-continuous (respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 01/20/2015
Decision Date: 09/15/2015
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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