510(k) K082420
K082420 is an FDA 510(k) premarket notification submitted by Etview for the device "TRACHEOSCOPIC VENTILATION TUBE (TVT)". The FDA issued a decision of Substantially Equivalent on October 8, 2008. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Etview has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2008
- Date Received
- August 22, 2008
- Clearance Type
- Special
- 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