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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K053369
Device Name MEDILOG DARWIN HOLTER ANALYSIS
Applicant
Huntleigh Healthcare
Lion House; Oriental Rd.
Working
Surrey,  GB GU22 8 AP
Applicant Contact JAMES PARDEY
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact STEFAN PREISS
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/05/2005
Decision Date 12/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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