FDA 510(k), K150638, AF541 SE Full Face Mask
FDA 510(k), K150638, AF541 SE Full Face Mask
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$149.00 USD
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$149.00 USD
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510(K) Number: K150638
Device Name: AF541 SE Full Face Mask
Manufacturer: Respironics, Inc.
Device Classification Name: ventilator, continuous, facility use
Regulation Number: 868.5895
Classification Product Code: CBK
Date Received: 03/11/2015
Decision Date: 09/18/2015
Regulation Medical Specialty: Anesthesiology
Device Name: AF541 SE Full Face Mask
Manufacturer: Respironics, Inc.
Device Classification Name: ventilator, continuous, facility use
Regulation Number: 868.5895
Classification Product Code: CBK
Date Received: 03/11/2015
Decision Date: 09/18/2015
Regulation Medical Specialty: Anesthesiology