TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041


Device Classification Name

thermometer, electronic, clinical

510(k) Number K073366
Device Name TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041
Applicant
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
340 shady grove road
flintville, 
TN 
37335

Applicant Contact charles mack
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 11/30/2007
Decision Date 02/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party Yes

Combination Product

No