Clearance Summary
SSIR SYSTEM received FDA 510(k) clearance under submission number K014208, sponsored by Russian-American Technology Associates, 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 2002-07-02.
- Submission: K014208
- Applicant / Sponsor: Russian-American Technology Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2002-07-02
Classification & Regulation
This clearance is catalogued under FDA product code ILY and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.