INFRARED EAR THEROMETER


Device Classification Name

thermometer, electronic, clinical

510(k) Number K111703
Device Name INFRARED EAR THEROMETER
Applicant
FUDAKANG INDUSTRIAL CO LTD
205 s. broadway, suite 718
los angeles, 
CA 
90012

Applicant Contact daniel nam
Correspondent
FUDAKANG INDUSTRIAL CO LTD
205 s. broadway, suite 718
los angeles, 
CA 
90012

Correspodent Contact daniel nam
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 06/17/2011
Decision Date 03/29/2012
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