510(k) K944178
K944178 is an FDA 510(k) premarket notification submitted by Bivona Medical Technologies for the device "BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES". The FDA issued a decision of Substantially Equivalent on Oct 27, 1994. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Bivona Medical Technologies has 49 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 27, 1994
- Date Received
- Aug 26, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Tube Tracheostomy And Tube Cuff
- Device Class
- Class II
- Regulation Number
- 868.5800
- Review Panel
- AN
- Submission Type
- 510(k)