DIGITAL CLINICAL THERMOMETER MODEL V901US


Device Classification Name

thermometer, electronic, clinical

510(k) Number K112116
Device Name DIGITAL CLINICAL THERMOMETER MODEL V901US
Applicant
AMPEROR-ELECTRONIC(SZ) CO., LTD
250 turnpike road
southborough, 
MA 
01772

Applicant Contact raj kasbekar
Correspondent
AMPEROR-ELECTRONIC(SZ) CO., LTD
250 turnpike road
southborough, 
MA 
01772

Correspodent Contact raj kasbekar
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 07/25/2011
Decision Date 10/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No