510(k) K173384
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube by
Smiths Medical Ads, Inc.
— Product Code BTO
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2018
- Date Received
- October 30, 2017
- 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