ENVITEC MYSIGN O OXYGEN MEASURING DEVICE


Device Classification Name

analyzer, gas, oxygen, gaseous-phase

510(k) Number K122290
Device Name ENVITEC MYSIGN O OXYGEN MEASURING DEVICE
Applicant
ENVITEC-WISMAR GMBH
s65 w35739 piper road
eagle, 
WI 
53119

Applicant Contact stephen gorski
Correspondent
ENVITEC-WISMAR GMBH
s65 w35739 piper road
eagle, 
WI 
53119

Correspodent Contact stephen gorski
Regulation Number 868.1720
Classification Product Code
CCL  
Date Received 07/30/2012
Decision Date 01/23/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No