510(k) K971759

MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER by Green Field Medical Sourcing, Inc. — Product Code BTR

K971759 is an FDA 510(k) premarket notification submitted by Green Field Medical Sourcing, Inc. for the device "MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER". The FDA issued a decision of Substantially Equivalent on March 2, 1998. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Green Field Medical Sourcing, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1998
Date Received
May 12, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type