WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H


Device Classification Name

thermometer, electronic, clinical

510(k) Number K081256
Device Name WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H
Applicant
RIO FLEXON TECHNOLOGY CO., LTD.
15f,868-2, jhong jheng rd.,
jhonghe city taipei county, 

TW

235

Applicant Contact chi-hung liao
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 05/02/2008
Decision Date 05/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No