CARDINAL SCALE MANUFACTURING COMPANY

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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

Scale, Patient (FRW) (7) Scale, Stand-On, Patient (FRI) (2) Scale, Surgical Sponge (FQA) (1)

Premarket Exempt

Yes

Clear

Detecto - 00809161140705 Catalog Number :

Device Description : Baby Scale, Digital, 30 lb x .1 oz / 15 kg x .005 kg

Device Class : 1

Duns Number: 007153505

Premarket Exempt : Yes

Product Code : FRW

Prescription Use : No

Device Count : 1

Detecto - 00809161140903 Catalog Number :

Device Description : Baby Scale, Digital, Seat, 44 lb x .05 lb / 20 kg x .02 kg

Device Class : 1

Duns Number: 007153505

Premarket Exempt : Yes

Product Code : FRW

Prescription Use : No

Device Count : 1

Detecto - 00809161141009 Catalog Number :

Device Description : Baby Scale, Digital, Tray, 130 lb x .1 lb / 59 kg x .5 kg

Device Class : 1

Duns Number: 007153505

Premarket Exempt : Yes

Product Code : FRW

Prescription Use : No

Device Count : 1

Detecto - 00809161141207 Catalog Number :

Device Description : BABY SCALE 44 lb x 1/2 oz

Device Class : 1

Duns Number: 007153505

Premarket Exempt : Yes

Product Code : FRW

Prescription Use : No

Device Count : 1

Detecto - 00809161142006 Catalog Number :

Device Description : Baby Scale, Dial, Hanging Sling Seat, 25 kg X 100 g

Device Class : 1

Duns Number: 007153505

Premarket Exempt : Yes

Product Code : FRW

Prescription Use : No

Device Count : 1

Detecto - 00809161142402 Catalog Number :

Device Description : Baby Scale, Weighbeam, Tray, 130 lb x 1 oz

Device Class : 1

Duns Number: 007153505

Premarket Exempt : Yes

Product Code : FRW

Prescription Use : No

Device Count : 1

Detecto - 00809161142501 Catalog Number :

Device Description : Baby Scale, Weighbeam, Tray, 65 kg x 20 g

Device Class : 1

Duns Number: 007153505

Premarket Exempt : Yes

Product Code : FRW

Prescription Use : No

Device Count : 1

Detecto - 00809161142709 Catalog Number :

Device Description : Diaper/Lap Sponge Scale, Digital, 4000 g x 1 g

Device Class : 1

Duns Number: 007153505

Premarket Exempt : Yes

Product Code : FQA

Prescription Use : No

Device Count : 1

Detecto - 00809161143904 Catalog Number :

Device Description : Healthcare Scale, Digital, 400 lb x .5 lb / 180 kg x .2 kg

Device Class : 1

Duns Number: 007153505

Premarket Exempt : Yes

Product Code : FRI

Prescription Use : No

Device Count : 1

Detecto - 00809161144000 Catalog Number :

Device Description : Healthcare Scale, Digital, 550 lb x .2 lb / 250 kg x .1 kg

Device Class : 1

Duns Number: 007153505

Premarket Exempt : Yes

Product Code : FRI

Prescription Use : No

Device Count : 1

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