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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, halothane, gaseous-phase (anesthetic conc.)
510(k) Number K932389
Device Name 8100 ANESTHETIC AGENT MONITOR
Applicant
BIOCHEM INTERNATIONAL, INC.
W238 N1650 ROCKWOOD DR.
WAUKESHA,  WI  53186
Applicant Contact SCOTT J PEASE
Correspondent
BIOCHEM INTERNATIONAL, INC.
W238 N1650 ROCKWOOD DR.
WAUKESHA,  WI  53186
Correspondent Contact SCOTT J PEASE
Regulation Number868.1620
Classification Product Code
CBS  
Date Received05/17/1993
Decision Date 12/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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