ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)


Device Classification Name

analyzer, gas, carbon-dioxide, gaseous-phase

510(k) Number K954402
Device Name ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)
Applicant
ICOR AB
ulvsundavagen 178 b
bromma, 

SE

161 30

Applicant Contact andras gedeon
Correspondent
ICOR AB
ulvsundavagen 178 b
bromma, 

SE

161 30

Correspodent Contact andras gedeon
Regulation Number 868.1400
Classification Product Code
CCK  
Date Received 09/20/1995
Decision Date 05/22/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No