510(k) K142971

AMT Bridle - Nasal Tube Retention System by Applied Medical Technology, Inc. — Product Code KNT

K142971 is an FDA 510(k) premarket notification submitted by Applied Medical Technology, Inc. for the device "AMT Bridle - Nasal Tube Retention System". The FDA issued a decision of Substantially Equivalent on May 26, 2015. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Applied Medical Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2015
Date Received
October 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type