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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K854333
Device Name BIOCHEM 515 RESPIRATION MONITOR
Applicant
Biochem International, Inc.
W238 N1650 Rockwood Dr.
Waukesha,  WI  53186
Applicant Contact KEITH R HARPER
Correspondent
Biochem International, Inc.
W238 N1650 Rockwood Dr.
Waukesha,  WI  53186
Correspondent Contact KEITH R HARPER
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received10/28/1985
Decision Date 05/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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