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

Astra Spirometer - B279295405PO050 Catalog Number : 29-5405PO-050

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295405PO1 Catalog Number : 29-5405PO

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295405S050 Catalog Number : 29-5405S-050

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295405S1 Catalog Number : 29-5405S

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295405SPO050 Catalog Number : 29-5405SPO-050

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295405SPO1 Catalog Number : 29-5405SPO

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

FloSense - B279298010F1 Catalog Number : 298010F

Device Description : Pneumotachometer

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : JAX

Prescription Use : No

Device Count : 50

FloSense - B279298010K1 Catalog Number : 298010K

Device Description : Pneumotachometer

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : JAX

Prescription Use : No

Device Count : 50

FloSense - B279298012F1 Catalog Number : 298012F

Device Description : Pneumotachometer

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : JAX

Prescription Use : No

Device Count : 250

FloSense - B279298012K1 Catalog Number : 298012K

Device Description : Pneumotachometer

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : JAX

Prescription Use : No

Device Count : 250

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