MEMTEC CORPORATION

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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

Recorder, Magnetic Tape, Medical (DSH) (1)

Premarket Exempt

Clear

Holter Monitor - 00860002827308 Catalog Number : 1

Device Description : Holter Monitor

Device Class : 2

Duns Number: 001048925

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

MobileECG System - 00860002827315 Catalog Number :

Device Description : PC Based Wireless 12 Lead EKG Device

Device Class :

Duns Number: 001048925

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

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