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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocardiograph
510(k) Number K011436
Device Name MOBILE-PATIENT VIEWER
Applicant
DATA CRITICAL CORPORATION
15222 DEL AMO AVE.
tustin,  CA  92780
Applicant Contact florin truuvert
Correspondent
DATA CRITICAL CORPORATION
15222 DEL AMO AVE.
tustin,  CA  92780
Correspondent Contact florin truuvert
Regulation Number870.2340
Classification Product Code
DPS  
Date Received05/10/2001
Decision Date 07/05/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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