ION HEALTH USB INSTA-SCAN THERMOMETER


Device Classification Name

thermometer, electronic, clinical

510(k) Number K111974
Device Name ION HEALTH USB INSTA-SCAN THERMOMETER
Applicant
TaiDoc Technology Corporation
3f,5f, no.127 wugong 2nd rd,
wugu district
new taipei city, 

TW

24888

Applicant Contact teling hsu
Correspondent
TaiDoc Technology Corporation
3f,5f, no.127 wugong 2nd rd,
wugu district
new taipei city, 

TW

24888

Correspodent Contact teling hsu
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 07/12/2011
Decision Date 08/15/2011
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