510(k) K853051
K853051 is an FDA 510(k) premarket notification submitted by Erie Medical for the device "TRACHEAL TUBES". The FDA issued a decision of Substantially Equivalent on April 11, 1986. 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
- April 11, 1986
- Date Received
- July 19, 1985
- 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