510(k) K973191
K973191 is an FDA 510(k) premarket notification submitted by Pulmonx for the device "THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM". The FDA issued a decision of Substantially Equivalent on February 13, 1998. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Pulmonx has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1998
- Date Received
- August 25, 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