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FDA 510(k), K161487, VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
FDA 510(k), K161487, VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
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510(K) Number: K161487
Device Name: VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
Manufacturer: ResMed Ltd
Device Classification Name: Ventilator, Continuous, Non-Life-Supporting
Regulation Number: 868.5895
Classification Product Code: MNS
Date Received: 05/31/2016
Decision Date: 09/09/2016
Regulation Medical Specialty: Anesthesiology
Device Name: VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
Manufacturer: ResMed Ltd
Device Classification Name: Ventilator, Continuous, Non-Life-Supporting
Regulation Number: 868.5895
Classification Product Code: MNS
Date Received: 05/31/2016
Decision Date: 09/09/2016
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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