510(k) K211543

Wei Nasal Jet Tube by Well Lead Medical Co., Ltd. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2022
Date Received
May 19, 2021
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