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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K853303
Device Name LIFELINC LEADWIRE
Applicant
TRONOMED, INC.
2811 MCGAW
IRVINE,  CA  92714
Applicant Contact JIM LELTEN
Correspondent
TRONOMED, INC.
2811 MCGAW
IRVINE,  CA  92714
Correspondent Contact JIM LELTEN
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received08/06/1985
Decision Date 09/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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