CARDIO CALM SRL

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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

Computer, Diagnostic, Programmable (DQK) (2)

Premarket Exempt

Clear

CER-S - B972CCZ12050482030 Catalog Number :

Device Description : CER-S is stand-alone software medical device, providing advanced solutions for i CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.

Device Class : 2

Duns Number: 431076243

Premarket Exempt : No

Product Code : DQK

Prescription Use : No

Device Count : 1

CER-S - B972CCZ12050482050 Catalog Number : CCZ1205048205

Device Class : 2

Duns Number: 431076243

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

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