Clearance Summary
PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A received FDA 510(k) clearance under submission number K801866, sponsored by Pentax Precision Instrument Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1980-09-16.
- Submission: K801866
- Applicant / Sponsor: Pentax Precision Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4750
- Decision date: 1980-09-16
Classification & Regulation
This clearance is catalogued under FDA product code EQL and 21 CFR 874.4750, within the Ear, Nose, Throat review panel as a Class I device.