CAPNOSTREAM20P WITH AI/ODI


Device Classification Name

analyzer, gas, carbon-dioxide, gaseous-phase

510(k) Number K112368
Device Name CAPNOSTREAM20P WITH AI/ODI
Applicant
ORIDION MEDICAL 1987 LTD.
7 hamarpe street, har
hotzvim industrial park
jerusalem, 

IL

91450

Applicant Contact rachel weissbrod
Correspondent
ORIDION MEDICAL 1987 LTD.
7 hamarpe street, har
hotzvim industrial park
jerusalem, 

IL

91450

Correspodent Contact rachel weissbrod
Regulation Number 868.1400
Classification Product Code
CCK  
Subsequent Product Codes
DQA   MNR  
Date Received 08/17/2011
Decision Date 07/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No