Alivecor, Inc.

Address:189 N Bernardo Avenue,Mountain View,CA,94043,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

Transmitters And Receivers, Electrocardiograph, Telephone (DXH) (3) Electrocardiograph (DPS) (2) Electrocardiograph Software For Over-The-Counter Use (QDA) (2)

Premarket Exempt

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Kardia Mobile - B210AC0090 Catalog Number :

Device Class : 2

Duns Number: 078523613

Premarket Exempt : No

Product Code : DXH

Prescription Use : No

Device Count : 1

KardiaMobile 6L - B210AC0190 Catalog Number :

Device Class : 2

Duns Number: 078523613

Premarket Exempt : No

Product Code : DXH, QDA, DPS

Prescription Use : Yes

Device Count : 1

KardiaMobile Card - B210AC0210 Catalog Number :

Device Description : The AliveCor KardiaMobile Card System is a single-channel electrocardiogram (ECG The AliveCor KardiaMobile Card System is a single-channel electrocardiogram (ECG) device that is intended to record, store, transfer, display, and analyze single-channel ECG rhythms.

Device Class : 2

Duns Number: 078523613

Premarket Exempt : No

Product Code : DXH, DPS, QDA

Prescription Use : Yes

Device Count : 1

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