Clearance Summary
ASC 4080 SYSTEM received FDA 510(k) clearance under submission number K843634, sponsored by Atlantis Scientific Corp.. 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 1984-11-08.
- Submission: K843634
- Applicant / Sponsor: Atlantis Scientific Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.1615
- Decision date: 1984-11-08
Classification & Regulation
This clearance is catalogued under FDA product code IKE and 21 CFR 890.1615, within the Physical Medicine review panel as a Class I device.