MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K021305
Device Name MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER
Original Applicant
MICROLIFE CORP.
55 northern blvd.
suite 200
great neck, 
NY 
11021

Original Contact susan d goldstein-falk
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 04/24/2002
Decision Date 06/28/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No