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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K082045
Device Name MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
Applicant
Spacelabs Medical, Inc.
2235 E. Flamingo Rd., Suite 201g
Las Vegas,  NV  89119
Applicant Contact TIM DAVIS
Correspondent
Spacelabs Medical, Inc.
2235 E. Flamingo Rd., Suite 201g
Las Vegas,  NV  89119
Correspondent Contact TIM DAVIS
Regulation Number870.1025
Classification Product Code
MHX  
Date Received07/18/2008
Decision Date 08/01/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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