HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES


Device Classification Name

thermometer, electronic, clinical

510(k) Number K081061
Device Name HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES
Applicant
HARVARD MEDICAL DEVICES LTD.
39 chatham road south
tsimshatsui, kowloon, 

HK

Applicant Contact paul aylett
Correspondent
HARVARD MEDICAL DEVICES LTD.
39 chatham road south
tsimshatsui, kowloon, 

HK

Correspodent Contact paul aylett
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 04/14/2008
Decision Date 07/18/2008
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