Clearance Summary
PUPIL PATHWAY ANALYZER (PPA) received FDA 510(k) clearance under submission number K895609, sponsored by Pulse Medical Instruments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1989-11-02.
- Submission: K895609
- Applicant / Sponsor: Pulse Medical Instruments
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1700
- Decision date: 1989-11-02
Classification & Regulation
This clearance is catalogued under FDA product code HLG and 21 CFR 886.1700, within the Ophthalmic review panel as a Class I device.