TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K022783
Device Name TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM
Original Applicant
TENSYS MEDICAL, INC.
5825 oberlin dr.
suite 100
san diego, 
CA 
92121

Original Contact stuart l gallant
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 08/22/2002
Decision Date 11/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No