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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Esophageal, With Electrical Conductors
510(k) Number K092716
Device Name ESOPHAGEAL STETHOSCOPE
Applicant
Truer Medical, Inc.
1050 N Batavia St.
Orange,  CA  92867
Applicant Contact TIM TRUITT
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number868.1920
Classification Product Code
BZT  
Date Received09/03/2009
Decision Date 09/17/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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