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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 K780158
Device Name TELETRACE TELEPHONE EKG TRANSMITTER
Applicant
Medtronic Vascular
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Medtronic Vascular
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2920
Classification Product Code
DXH  
Date Received01/30/1978
Decision Date 03/21/1978
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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