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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact DAVID MOYNHAM
Regulation Number870.2780
Classification Product Code
JOM  
Date Received04/12/2012
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
Predetermined Change
Control Plan Authorized		 No
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