Clearance Summary
THE VIVACARE T.P.S. PROBE received FDA 510(k) clearance under submission number K944848, sponsored by Rms Div.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-12-14.
- Submission: K944848
- Applicant / Sponsor: Rms Div.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1994-12-14
Classification & Regulation
This clearance is catalogued under FDA product code EIX and 21 CFR 872.4565, within the Dental review panel as a Class I device.