Clearance Summary
FORTRESS 1000FS ADD-ON POWER UNIT received FDA 510(k) clearance under submission number K895596, sponsored by Fortress Scientific , Ltd.. 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 1989-10-23.
- Submission: K895596
- Applicant / Sponsor: Fortress Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3860
- Decision date: 1989-10-23
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.