Clearance Summary
JTECH COMMANDER AND ALGOMETER received FDA 510(k) clearance under submission number K971407, sponsored by J-Tech Medical, 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 1998-04-20.
- Submission: K971407
- Applicant / Sponsor: J-Tech Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.1250
- Decision date: 1998-04-20
Classification & Regulation
This clearance is catalogued under FDA product code HRW and 21 CFR 888.1250, within the Orthopedic review panel as a Class I device.