FUTUREMED AMERICA, INC.

Address:15700 Devonshire St,GRANADA HILLS,CA,91344,US

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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

Filter, Bacterial, Breathing-Circuit (CAH) (4) Spirometer, Diagnostic (BZG) (2) Calculator, Predicted Values, Pulmonary Function (BTY) (1) Calculator, Pulmonary Function Data (BZC) (1)

Premarket Exempt

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FUTUREMED - 00853452007017 Catalog Number :

Device Description : Futuremed Discovery-2 diagnostic spirometer

Device Class : 2

Duns Number: 195929658

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

FUTUREMED - 00853452007024 Catalog Number :

Device Description : SPIROVISION PC BASED SPIROMETER

Device Class : 2

Duns Number: 195929658

Premarket Exempt : No

Product Code : BZG, BTY, BZC

Prescription Use : Yes

Device Count : 1

FUTUREMED - 00853452007178 Catalog Number : 39NAE-XXX

Device Description : Futuremed Spirometry filter with oval mouthpiece, for use with pulmonary functio Futuremed Spirometry filter with oval mouthpiece, for use with pulmonary function testing equipment. 31mm OD.

Device Class : 2

Duns Number: 195929658

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

FUTUREMED - 00853452007208 Catalog Number : 39298-Bulk

Device Description : Futuremed spirometry filter with round mouthpiece for use with pulmonary functio Futuremed spirometry filter with round mouthpiece for use with pulmonary function testing equipment. 30mm OD.

Device Class :

Duns Number: 195929658

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

FUTUREMED - 00853452007307 Catalog Number : 39XXX-02E

Device Description : Futuremed Spirometry Filter with oval mouthpiece for use with pulmonary function Futuremed Spirometry Filter with oval mouthpiece for use with pulmonary function testing equipment. 35mm OD.

Device Class : 2

Duns Number: 195929658

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

FUTUREMED - 00853452007406 Catalog Number : 39XXX-03

Device Description : Futuremed spirometry filter with round mouthpiece, for use with pulmonary functi Futuremed spirometry filter with round mouthpiece, for use with pulmonary function equipment. 48mm OD.

Device Class : 2

Duns Number: 195929658

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

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