Clearance Summary
STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 received FDA 510(k) clearance under submission number K942694, sponsored by Biodex Medical Systems, 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 1995-03-10.
- Submission: K942694
- Applicant / Sponsor: Biodex Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.1575
- Decision date: 1995-03-10
Classification & Regulation
This clearance is catalogued under FDA product code KHX and 21 CFR 890.1575, within the Physical Medicine review panel as a Class I device.