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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K081572
Device Name SMARTSIGNS MINPULSE
Applicant
HUNTLEIGH HEALTHCARE LTD.
35 PORTMANMOOR RD.
CARDIFF, SOUTH GLAMORGAN,  GB CF24 5HN
Applicant Contact ROBERT MCCARTHY
Correspondent
HUNTLEIGH HEALTHCARE LTD.
35 PORTMANMOOR RD.
CARDIFF, SOUTH GLAMORGAN,  GB CF24 5HN
Correspondent Contact ROBERT MCCARTHY
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/04/2008
Decision Date 10/01/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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