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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, Electrocardiograph, Telephone
510(k) Number K923930
Device Name ELECTROCARDIOGRAPH TRANSMITTER
Applicant
Tz Medical, Inc.
18603 Willamette Dr.
West Linn,  OR  97068
Applicant Contact BYRON G ZAHLER
Correspondent
Tz Medical, Inc.
18603 Willamette Dr.
West Linn,  OR  97068
Correspondent Contact BYRON G ZAHLER
Regulation Number870.2920
Classification Product Code
DXH  
Date Received08/05/1992
Decision Date 10/21/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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