HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K081159
Device Name HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 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 870.1130
Classification Product Code
DXN  
Date Received 04/14/2008
Decision Date 08/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No