510(k) K152778
K152778 is an FDA 510(k) premarket notification submitted by Tracoe Medical GmbH for the device "TRACOE Cuff Pressure Monitor". The FDA issued a decision of Substantially Equivalent on December 21, 2016. The device falls under product code BSK (Cuff, Tracheal Tube, Inflatable), a Class II device regulated under 21 CFR 868.5750. Tracoe Medical GmbH has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2016
- Date Received
- September 25, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cuff, Tracheal Tube, Inflatable
- Device Class
- Class II
- Regulation Number
- 868.5750
- Review Panel
- AN
- Submission Type