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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 ROAD
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
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