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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 K983996
Device Name SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM
Applicant
Spacelabs Medical, Inc.
15220 NE 40th St.
Redmond,  WA  98073
Applicant Contact NANCY J GERTLAR
Correspondent
Spacelabs Medical, Inc.
15220 NE 40th St.
Redmond,  WA  98073
Correspondent Contact NANCY J GERTLAR
Regulation Number870.1025
Classification Product Code
MHX  
Date Received11/10/1998
Decision Date 06/03/1999
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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