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FDA 510(k), K150639, AF541 EE Full Face Mask
FDA 510(k), K150639, AF541 EE Full Face Mask
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510(K) Number: K150639
Device Name: AF541 EE Full Face Mask
Manufacturer: RESPIRONICS, INC.
Device Classification Name: ventilator, non-continuous (respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 03/11/2015
Decision Date: 09/18/2015
Regulation Medical Specialty: Anesthesiology
Device Name: AF541 EE Full Face Mask
Manufacturer: RESPIRONICS, INC.
Device Classification Name: ventilator, non-continuous (respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 03/11/2015
Decision Date: 09/18/2015
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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