JASUN, MODELS DT-01F AND DT-11F


Device Classification Name

thermometer, electronic, clinical

510(k) Number K030361
Device Name JASUN, MODELS DT-01F AND DT-11F
Applicant
HANGZHOU HUA’AN MEDICAL & HEALTH INSTRUMENTS CO.,
4960 tamarack dr.
barrington, 
IL 
60010

Applicant Contact ting lu
Correspondent
HANGZHOU HUA’AN MEDICAL & HEALTH INSTRUMENTS CO.,
4960 tamarack dr.
barrington, 
IL 
60010

Correspodent Contact ting lu
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 02/03/2003
Decision Date 02/21/2003
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