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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 K992749
Device Name ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841
Applicant
Spacelabs Medical, Inc.
15220 N. E. 40th St.
P.O. Box 97013
Redmond,  WA  98052
Applicant Contact NANCY GERTLAR
Correspondent
Spacelabs Medical, Inc.
15220 N. E. 40th St.
P.O. Box 97013
Redmond,  WA  98052
Correspondent Contact NANCY GERTLAR
Regulation Number870.2300
Classification Product Code
MSX  
Date Received08/16/1999
Decision Date 01/14/2000
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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