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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transmitters and receivers, electrocardiograph, telephone
510(k) Number K971650
Device Name RHYTHMSTAT XL
Applicant
DATA CRITICAL CORP.
9223 ILONA LN.
houston,  TX  77025 -4218
Applicant Contact lisa s jones
Correspondent
DATA CRITICAL CORP.
9223 ILONA LN.
houston,  TX  77025 -4218
Correspondent Contact lisa s jones
Regulation Number870.2920
Classification Product Code
DXH  
Date Received05/06/1997
Decision Date 12/04/1997
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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