DOPPLEX ABILITY


Device Classification Name

plethysmograph, photoelectric, pneumatic or hydraulic

510(k) Number K121108
Device Name DOPPLEX ABILITY
Applicant
HUNTLEIGH HEALTHCARE
35 portmanmoor road
cardiff, 

GB

cf24 5hn

Applicant Contact david moynham
Correspondent
HUNTLEIGH HEALTHCARE
35 portmanmoor road
cardiff, 

GB

cf24 5hn

Correspodent Contact david moynham
Regulation Number 870.2780
Classification Product Code
JOM  
Date Received 04/12/2012
Decision Date 01/03/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No