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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 K102422
Device Name SPACELABS MEDICAL PATIENT MONITORS
Applicant
SPACELABS MEDICAL INC.
5150 220TH AVE SE
ISSAQUAH,  WA  98029
Applicant Contact DAVID J GERAGHTY
Correspondent
SPACELABS MEDICAL INC.
5150 220TH AVE SE
ISSAQUAH,  WA  98029
Correspondent Contact DAVID J GERAGHTY
Regulation Number870.1025
Classification Product Code
MHX  
Date Received08/25/2010
Decision Date 12/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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