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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K974567
Device Name HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER
Applicant
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810 -1085
Applicant Contact RAY STELTING
Correspondent
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810 -1085
Correspondent Contact RAY STELTING
Regulation Number870.2300
Classification Product Code
MSX  
Date Received12/05/1997
Decision Date 01/20/1998
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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