Clearance Summary
PREMIER received FDA 510(k) clearance under submission number K834552, sponsored by Everest & Jennings, 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 1984-01-30.
- Submission: K834552
- Applicant / Sponsor: Everest & Jennings, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3860
- Decision date: 1984-01-30
Classification & Regulation
This clearance is catalogued under FDA product code ITI and 21 CFR 890.3860, within the Physical Medicine review panel as a Class II device.