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FDA 510(k), K151683, SleepWeaver Advance Pediatric Nasal CPAP Mask
FDA 510(k), K151683, SleepWeaver Advance Pediatric Nasal CPAP Mask
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$149.00 USD
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510(K) Number: K151683
Device Name: SleepWeaver Advance Pediatric Nasal CPAP Mask
Manufacturer: Circadiance, LLC
Device Classification Name: ventilator, non-continuous (respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 06/22/2015
Decision Date: 04/05/2016
Regulation Medical Specialty: Anesthesiology
Device Name: SleepWeaver Advance Pediatric Nasal CPAP Mask
Manufacturer: Circadiance, LLC
Device Classification Name: ventilator, non-continuous (respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 06/22/2015
Decision Date: 04/05/2016
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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