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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 K904748
Device Name TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100
Applicant
Transtracheal Systems
110 Shawmut Rd.
Canton,  MA  02021
Applicant Contact JOHN G GREGORY
Correspondent
Transtracheal Systems
110 Shawmut Rd.
Canton,  MA  02021
Correspondent Contact JOHN G GREGORY
Regulation Number870.2910
Classification Product Code
DRG  
Date Received10/19/1990
Decision Date 03/01/1991
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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