Clearance Summary
INCLINOMETER received FDA 510(k) clearance under submission number K954647, sponsored by J-Tech, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1995-10-30.
- Submission: K954647
- Applicant / Sponsor: J-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.1500
- Decision date: 1995-10-30
Classification & Regulation
This clearance is catalogued under FDA product code KQX and 21 CFR 888.1500, within the Orthopedic review panel as a Class I device.