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 - B279295300D1 Catalog Number : 29-5300D

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295300P1 Catalog Number : 29-5300P

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295300R1 Catalog Number : 29-5300R

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295301P050 Catalog Number : 29-5301P-050

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295302BT1 Catalog Number : 29-5302BT

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295302S050 Catalog Number : 29-5302S-050

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295302S1 Catalog Number : 29-5302S

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295400D1 Catalog Number : 29-5400D

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295403S050 Catalog Number : 29-5403S-050

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295403S1 Catalog Number : 29-5403S

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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