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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 K140134
Device Name ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE
Applicant
Starboard Medical, LLC
22845 Savi Ranch Pkwy. Suite H
Yorba Linda,  CA  92887
Applicant Contact ANTHONY BERAN
Correspondent
Starboard Medical, LLC
22845 Savi Ranch Pkwy. Suite H
Yorba Linda,  CA  92887
Correspondent Contact ANTHONY BERAN
Regulation Number868.1920
Classification Product Code
BZT  
Subsequent Product Code
FLL  
Date Received01/17/2014
Decision Date 06/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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