Clearance Summary
MODEL 938 BATHING SYSTEM received FDA 510(k) clearance under submission number K880355, sponsored by Ferno Ille-Forge. 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 1988-02-16.
- Submission: K880355
- Applicant / Sponsor: Ferno Ille-Forge
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5100
- Decision date: 1988-02-16
Classification & Regulation
This clearance is catalogued under FDA product code ILJ and 21 CFR 890.5100, within the Physical Medicine review panel as a Class II device.