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FDA 510(k) Application Details - K140097
Device Classification Name
Device, Fixation, Tracheal Tube
More FDA Info for this Device
510(K) Number
K140097
Device Name
Device, Fixation, Tracheal Tube
Applicant
APPLIED MEDICAL TECHNOLOGY, INC.
8000 KATHERINE BOULEVARD
BRECKSVILLE, OH 44141 US
Other 510(k) Applications for this Company
Contact
JOSHUA MEINKE
Other 510(k) Applications for this Contact
Regulation Number
868.5770
More FDA Info for this Regulation Number
Classification Product Code
CBH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/14/2014
Decision Date
09/24/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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