S D I DIAGNOSTICS INC

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Filters

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, Diagnostic (BZG) (6) Pneumotachometer (JAX) (4)

Premarket Exempt

No Yes

Clear

FloSense - B279298020F1 Catalog Number : 298020F

Device Description : Pneumotachometer

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : JAX

Prescription Use : No

Device Count : 25

FloSense - B279298020K1 Catalog Number : 298020K

Device Description : Pneumotachometer

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : JAX

Prescription Use : No

Device Count : 25

FloSense - B279298021F1 Catalog Number : 298021F

Device Description : Pneumotachometer

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : JAX

Prescription Use : No

Device Count : 100

FloSense - B279298021K1 Catalog Number : 298021K

Device Description : Pneumotachometer

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : JAX

Prescription Use : No

Device Count : 100

FloSense II - B279298040F050 Catalog Number : 29-8040F-050

Device Description : FloSense II

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 50

FloSense II - B279298040F100 Catalog Number : 29-8040F-100

Device Description : FloSense II

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 100

FloSense II - B279298040F250 Catalog Number : 29-8040F-250

Device Description : FloSense II

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 250

FloSense II - B279298040K050 Catalog Number : 29-8040K-050

Device Description : FloSense II

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 50

FloSense II - B279298040K100 Catalog Number : 29-8040K-100

Device Description : FloSense II

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 100

FloSense II - B279298040K250 Catalog Number : 29-8040K-250

Device Description : FloSense II

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 250

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