510(k) K833197
K833197 is an FDA 510(k) premarket notification submitted by Airlife, Inc. for the device "TRACH SWIVE/CONNECTOR". The FDA issued a decision of Substantially Equivalent on October 28, 1983. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Airlife, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 1983
- Date Received
- September 19, 1983
- 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