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FDA 510(k), K103410, NEOPAP SYSTEM
FDA 510(k), K103410, NEOPAP SYSTEM
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510(K) Number: K103410
Device Name: NEOPAP SYSTEM
Manufacturer: SCOTT WRIGHT
Device Classification Name: Ventilator, Non-Continuous (Respirator)
Regulation Number: BZD
Classification Product Code: 11/22/2010
Date Received: 03/30/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: NEOPAP SYSTEM
Manufacturer: SCOTT WRIGHT
Device Classification Name: Ventilator, Non-Continuous (Respirator)
Regulation Number: BZD
Classification Product Code: 11/22/2010
Date Received: 03/30/2011
Decision Date: Substantially Equivalent (SESE)
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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