Clearance Summary
AMX-110, AMX-II AND AMX-III received FDA 510(k) clearance under submission number K884340, sponsored by Dyna-Med. 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 1989-01-24.
- Submission: K884340
- Applicant / Sponsor: Dyna-Med
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5925
- Decision date: 1989-01-24
Classification & Regulation
This clearance is catalogued under FDA product code ILZ and 21 CFR 890.5925, within the Physical Medicine review panel as a Class I device.