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

Pneumotachometer (JAX) (9) Spirometer, Diagnostic (BZG) (1)

Premarket Exempt

No Yes

Clear

Mouthpiece - B279298050K025 Catalog Number : 29-8050K-025

Device Description : Mouthpiece

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 25

FloSense - B279DP2001 Catalog Number : DP200-1

Device Description : FloSense Sensor

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : JAX

Prescription Use : No

Device Count : 50

FloSense - B279DP2002 Catalog Number : DP200-2

Device Description : FloSense Sensor

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : JAX

Prescription Use : No

Device Count : 250

FloSense - B279DP2011 Catalog Number : DP201-1

Device Description : FloSense Sensor

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : JAX

Prescription Use : No

Device Count : 50

FloSense - B279DP2012 Catalog Number : DP201-2

Device Description : FloSense Sensor

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : JAX

Prescription Use : No

Device Count : 250

FloSense - B279DP2111 Catalog Number : DP211-1

Device Description : FloSense Sensor

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : JAX

Prescription Use : No

Device Count : 50

FloSense - B279DP2112 Catalog Number : DP211-2

Device Description : FloSense Sensor

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : JAX

Prescription Use : No

Device Count : 250

FloSense - B279DP2504 Catalog Number : DP250-4

Device Description : FloSense Sensor

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : JAX

Prescription Use : No

Device Count : 100

FloSense - B279DP2507 Catalog Number : DP250-7

Device Description : FloSense Sensor

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : JAX

Prescription Use : No

Device Count : 25

FloSense - B279DP2514 Catalog Number : DP251-4

Device Description : FloSense Sensor

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : JAX

Prescription Use : No

Device Count : 100

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