CardioComm Solutions, Inc

Address:18 Wynford Drive,North York Ontario,CA

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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

Electrocardiograph (DPS) (2) Transmitters And Receivers, Electrocardiograph, Telephone (DXH) (1)

Premarket Exempt

Clear

HeartCheck BT PEN Handheld ECG - 00812324000020 Catalog Number : HCEKGBTPEN30

Device Description : Bluetooth PEN Handheld ECG

Device Class : 2

Duns Number: 251043907

Premarket Exempt : No

Product Code : DPS

Prescription Use : No

Device Count : 1

HeartCheck CardiBeat - 00812324000044 Catalog Number : HC-WC-01

Device Description : HeartCheck CardiBeat portable ECG monitor

Device Class : 2

Duns Number: 251043907

Premarket Exempt : No

Product Code : DXH

Prescription Use : No

Device Count : 1

HeartCheck Palm - 00812324000136 Catalog Number : HC-PM10

Device Description : HeartCheck Palm Portable ECG

Device Class : 2

Duns Number: 251043907

Premarket Exempt : No

Product Code : DPS

Prescription Use : No

Device Count : 1

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