MEDICAL ACOUSTICS LLC

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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

Spirometer, Therapeutic (Incentive) (BWF) (3) Percussor, Powered-Electric (BYI) (1)

Premarket Exempt

Clear

Lung Flute® for Hospitals & Clinics - 00816133010003 Catalog Number : 1004-01

Device Description : Secretion Mobilization and Induction DeviceDual-Indication for Diagnostic & Ther Secretion Mobilization and Induction DeviceDual-Indication for Diagnostic & Therapeutic Use

Device Class : 2

Duns Number: 059669559

Premarket Exempt : No

Product Code : BWF, BYI

Prescription Use : Yes

Device Count : 1

Lung Flute® for Home Care - 00816133010010 Catalog Number : 1003-01

Device Description : Secretion Mobilization Device for PEP/Bronchial Hygiene Therapy

Device Class : 2

Duns Number: 059669559

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 1

Lung Flute® Therapeutic - 00816133010089 Catalog Number : 1005-01

Device Description : Secretion Mobilization Device for PEP/Bronchial Hygiene Therapy

Device Class : 2

Duns Number: 059669559

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 1

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