510(k) K200761
K200761 is an FDA 510(k) premarket notification submitted by Bryan Medical, Inc. for the device "Tenax Laser Resistant Endotracheal Tube". The FDA issued a decision of Substantially Equivalent on November 25, 2020. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Bryan Medical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 2020
- Date Received
- March 24, 2020
- 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