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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K844940
Device Name SPACELABS MODEL 90201 HOLTER RECORDER
Applicant
Spacelabs, Inc.
20550 Prairie St.
Chatsworth,  CA  91311
Applicant Contact ALLEN M HANS
Correspondent
Spacelabs, Inc.
20550 Prairie St.
Chatsworth,  CA  91311
Correspondent Contact ALLEN M HANS
Regulation Number870.2800
Classification Product Code
DSH  
Date Received12/20/1984
Decision Date 02/14/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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