Clearance Summary
I CARE received FDA 510(k) clearance under submission number K941442, sponsored by I Care Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1994-05-09.
- Submission: K941442
- Applicant / Sponsor: I Care Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1994-05-09
Classification & Regulation
This clearance is catalogued under FDA product code HQY and 21 CFR 886.5850, within the Ophthalmic review panel as a Class I device.