THERMO BUDDY, MODELS TB-100, TB-110, TB-120


Device Classification Name

thermometer, electronic, clinical

510(k) Number K023412
Device Name THERMO BUDDY, MODELS TB-100, TB-110, TB-120
Original Applicant
HUBDIC CO., LTD
11820 red hibiscus dr.
bonita springs, 
FL 
34135

Original Contact guenter ginsberg
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 10/11/2002
Decision Date 04/09/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No