Clearance Summary
ECOGEL 200 ULTRASOUND GEL received FDA 510(k) clearance under submission number K955246, sponsored by Eco-Med Pharmaceuticals, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1996-02-21.
- Submission: K955246
- Applicant / Sponsor: Eco-Med Pharmaceuticals, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 1996-02-21
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.