CAPNOCHECK II, MODEL 8400


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

Correspodent Contact donald alexander
Regulation Number 868.1400
Classification Product Code
CCK  
Date Received 03/31/1999
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