HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN


Device Classification Name

generator, oxygen, portable

510(k) Number K081508
Device Name HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN
Applicant
SHENYANG CANTA MEDICAL TECH CO., LTD.
suite 8d, no. 19, lane 999
zhongshan no.2 road (s)
shanghai, 

CN

200030

Applicant Contact diana hong
Correspondent
SHENYANG CANTA MEDICAL TECH CO., LTD.
suite 8d, no. 19, lane 999
zhongshan no.2 road (s)
shanghai, 

CN

200030

Correspodent Contact diana hong
Regulation Number 868.5440
Classification Product Code
CAW  
Date Received 05/29/2008
Decision Date 08/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No