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FDA 510(k) Application Details - K111050
Device Classification Name
Stethoscope, Esophageal, With Electrical Conductors
More FDA Info for this Device
510(K) Number
K111050
Device Name
Stethoscope, Esophageal, With Electrical Conductors
Applicant
STARBOARD MEDICAL, LLC
22845 SAVI RANCH PKWY
SUITE H
Yorba Linda, CA 92887 US
Other 510(k) Applications for this Company
Contact
ANTHONY BERAN
Other 510(k) Applications for this Contact
Regulation Number
868.1920
More FDA Info for this Regulation Number
Classification Product Code
BZT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/15/2011
Decision Date
04/12/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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