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) (10)

Premarket Exempt

No Yes

Clear

Astra Spirometer - B279SIB200D1 Catalog Number : SIB200D

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB201 Catalog Number : SIB201

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB201050 Catalog Number : SIB201-050

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB202 Catalog Number : SIB-202

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB202050 Catalog Number : SIB202-050

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB202S050 Catalog Number : SIB202S-050

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB202S1 Catalog Number : SIB202S

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB300 Catalog Number : SIB300

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB300D1 Catalog Number : SIB300D

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB300R1 Catalog Number : SIB300R

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

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