NOVAMED-USA INC.

Address:4 WESTCHESTER PLZ STE 137,Elmsford,NY,10523,US

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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

Stethoscope, Esophageal, With Electrical Conductors (BZT) (1) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

Clear

NOVATEMP - 00817499020200 Catalog Number :

Device Description : SKIN TEMPERATURE SENSOR WITH 700 SERIES THERMISTOR

Device Class : 2

Duns Number: 831531426

Premarket Exempt : No

Product Code : FLL

Prescription Use : Yes

Device Count : 1

LIFESOUND - 00817499020217 Catalog Number :

Device Description : 18FR ESOPHAGEAL STETHOSCOPE WITH 700 SERIES THERMISTOR

Device Class : 2

Duns Number: 831531426

Premarket Exempt : No

Product Code : BZT

Prescription Use : Yes

Device Count : 1

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