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 - B279SIB301 Catalog Number : SIB301

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB301050 Catalog Number : SIB301-050

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB302 Catalog Number : SIB302

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB302050 Catalog Number : SIB302-050

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB302S1 Catalog Number : SIB302S

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB400 Catalog Number : SIB400

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB400050 Catalog Number : SIB400-050

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB401 Catalog Number : SIB401

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB401050 Catalog Number : SIB401-050

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279SIB403 Catalog Number : SIB403

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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