MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER


Device Classification Name

thermometer, electronic, clinical

510(k) Number K021601
Device Name MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER
Original Applicant
DUTECK INDUSTRIAL CO., LTD.
3f-2, no. 26, 513 lane
jui-kuang road
taipei, 

TW

114

Original Contact yi-lang lin
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 05/15/2002
Decision Date 07/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No