Clearance Summary
DISTOMETER received FDA 510(k) clearance under submission number K882575, sponsored by Hagg-Streit Service, 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 1988-07-01.
- Submission: K882575
- Applicant / Sponsor: Hagg-Streit Service, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1190
- Decision date: 1988-07-01
Classification & Regulation
This clearance is catalogued under FDA product code HMM and 21 CFR 886.1190, within the Ophthalmic review panel as a Class I device.