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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Bed Patient
510(k) Number K101109
Device Name VIVATRAK
Applicant
Wireless Medcare, LLC
1733 Canton Ln.
Marietta,  GA  30062
Applicant Contact PAUL SUMNER
Correspondent
Wireless Medcare, LLC
1733 Canton Ln.
Marietta,  GA  30062
Correspondent Contact PAUL SUMNER
Regulation Number880.2400
Classification Product Code
KMI  
Date Received04/20/2010
Decision Date 07/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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