Clearance Summary
VISITHERM received FDA 510(k) clearance under submission number K852950, sponsored by C.D. Regelin & Associates, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1986-02-07.
- Submission: K852950
- Applicant / Sponsor: C.D. Regelin & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class III
- Regulation citation: 21 CFR 884.2980
- Decision date: 1986-02-07
Classification & Regulation
This clearance is catalogued under FDA product code IYM and 21 CFR 884.2980, within the Obstetrics/Gynecology review panel as a Class III device.