ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS


Device Classification Name

oximeter

510(k) Number K103584
Device Name ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS
Applicant
SHENZHEN ENVISEN INDUSTRY CO. LIMITED
s65 w35739 piper road
eagle, 
WI 
53119

Applicant Contact stephen h gorski
Correspondent
SHENZHEN ENVISEN INDUSTRY CO. LIMITED
s65 w35739 piper road
eagle, 
WI 
53119

Correspodent Contact stephen h gorski
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 12/07/2010
Decision Date 06/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No