DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038


Device Classification Name

thermometer, electronic, clinical

510(k) Number K021612
Device Name DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038
Original Applicant
ACTHERM, INC.
6th f, no 85
kuan-min 6 road jubei 302
hsinchu, 

TW

302

Original Contact richard hsieh
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 05/16/2002
Decision Date 05/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No