Clearance Summary
BREATH-EASY, MODIFICATION received FDA 510(k) clearance under submission number K914416, sponsored by Icor AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1992-06-23.
- Submission: K914416
- Applicant / Sponsor: Icor AB
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1140
- Decision date: 1992-06-23
Classification & Regulation
This clearance is catalogued under FDA product code HME and 21 CFR 886.1140, within the Ophthalmic review panel as a Class I device.