Clearance Summary
TRANS 2000 received FDA 510(k) clearance under submission number K771018, sponsored by Hamilton Industries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1977-07-14.
- Submission: K771018
- Applicant / Sponsor: Hamilton Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3690
- Decision date: 1977-07-14
Classification & Regulation
This clearance is catalogued under FDA product code INK and 21 CFR 890.3690, within the Physical Medicine review panel as a Class II device.