510(k) K211543
K211543 is an FDA 510(k) premarket notification submitted by Well Lead Medical Co., Ltd. for the device "Wei Nasal Jet Tube". The FDA issued a decision of Substantially Equivalent on July 21, 2022. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Well Lead Medical Co., Ltd. has at least 10 other 510(k) clearances on record.
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