Clearance Summary
CHAL-2500 received FDA 510(k) clearance under submission number K946186, sponsored by Hogan & Hartson. 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 1995-08-14.
- Submission: K946186
- Applicant / Sponsor: Hogan & Hartson
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 1995-08-14
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.