510(k) K161716
K161716 is an FDA 510(k) premarket notification submitted by Bts S.P.A. for the device "TEETHAN 2.0". The FDA issued a decision of Substantially Equivalent on December 21, 2016. The device falls under product code KZM (Device, Muscle Monitoring), a Class II device regulated under 21 CFR 890.1375. Bts S.P.A. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2016
- Date Received
- June 21, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Muscle Monitoring
- Device Class
- Class II
- Regulation Number
- 890.1375
- Review Panel
- DE
- Submission Type