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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 K062095
Device Name MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
Applicant
SPACELABS MEDICAL INC.
5150 220TH AVE SE
PO BOX 7018
ISSAQUAH, WA,  WA  98027 -7018
Applicant Contact DAVID J GERAGHTY
Correspondent
SPACELABS MEDICAL INC.
5150 220TH AVE SE
PO BOX 7018
ISSAQUAH, WA,  WA  98027 -7018
Correspondent Contact DAVID J GERAGHTY
Regulation Number870.1025
Classification Product Code
MHX  
Date Received07/24/2006
Decision Date 09/29/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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