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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K041816
Device Name RTX3320PSTN WIRELESS TELEHEALTH GATEWAY
Applicant
Rtx Healthcare A/S
Stroemmen 6
Noerresundby,  DK DK-9400
Applicant Contact NIELS OLE ANDERSEN
Correspondent
Kema Quality B.V.
4377 County Line Rd.
Chalfont,  PA  18914
Regulation Number870.2910
Classification Product Code
DRG  
Date Received07/06/2004
Decision Date 07/19/2004
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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