RESPINNOVATION

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Percussor, Powered-Electric (BYI) (1)

Premarket Exempt

Clear

RespIn - 03760251321107 Catalog Number :

Device Description : RespIn 11 Bronchial Airway Clearance System is a "Focused Pulse" High Frequency RespIn 11 Bronchial Airway Clearance System is a "Focused Pulse" High Frequency Chest Wall Oscillation (HFCWO) device that maximizes the use of modern technologies and materials to produce a more comfortable, flexible and effective therapy delivery system.

Device Class : 2

Duns Number: 262605672

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

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