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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 K991086
Device Name CAPNOCHECK II, MODEL 8400
Applicant
BCI INTL., INC.
N7 W22025 JOHNSON RD.
WAUKESHA,  WI  53186
Applicant Contact DONALD ALEXANDER
Correspondent
BCI INTL., INC.
N7 W22025 JOHNSON RD.
WAUKESHA,  WI  53186
Correspondent Contact DONALD ALEXANDER
Regulation Number868.1400
Classification Product Code
CCK  
Date Received03/31/1999
Decision Date 06/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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