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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, carbon-dioxide, gaseous-phase
510(k) Number K941971
Device Name 9100 MUTIGAS MONITOR
Applicant
BCI INTL., INC.
W238 N1650 ROCKWOOD DR.
WAUKESHA,  WI  53188
Applicant Contact SCOTT PEASE
Correspondent
BCI INTL., INC.
W238 N1650 ROCKWOOD DR.
WAUKESHA,  WI  53188
Correspondent Contact SCOTT PEASE
Regulation Number868.1400
Classification Product Code
CCK  
Date Received04/22/1994
Decision Date 11/21/1994
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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