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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K980429
Device Name HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY SYSTEM)
Applicant
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact RAY STELTING
Correspondent
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact RAY STELTING
Regulation Number870.1025
Classification Product Code
DSI  
Date Received02/04/1998
Decision Date 09/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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