CARDIAC DESIGNS INC.

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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) (1)

Premarket Exempt

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ECG Check - B287ECG01U0 Catalog Number : ECG01-Universal

Device Description : The ECG Check is intended for self-testing by patients at home. This 1-leadcardi The ECG Check is intended for self-testing by patients at home. This 1-leadcardiac monitor allows remote patients to display and transmit their EGG data tomedical professionals via a communication device to a remote server.Specifically, the EGG Check is indicated for patients who are concerned abouttheir heart rhythm and have experienced the following symptoms that aresuggestive of abnormal heart rhythms:* Skipped Beats* Pounding Heart (Palpitations)* Heart Racing or Irregular Pulse* Lightheadedness or Faintness* History of ArrhythmiasPrescription

Device Class : 2

Duns Number: 079693152

Premarket Exempt : No

Product Code : DXH

Prescription Use : Yes

Device Count : 1

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