510(k) K832466
K832466 is an FDA 510(k) premarket notification submitted by Erie Medical for the device "TRACHEAL TUBE 16 GAUGE-1.65MM-". The FDA issued a decision of Substantially Equivalent on September 19, 1984. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Erie Medical has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 1984
- Date Received
- July 26, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tracheostomy (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5800
- Review Panel
- AN
- Submission Type