Clearance Summary
HA-2000 REAL EAR SPECTROSCOPE received FDA 510(k) clearance under submission number K862026, sponsored by And/Or 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 1986-08-15.
- Submission: K862026
- Applicant / Sponsor: And/Or Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3310
- Decision date: 1986-08-15
Classification & Regulation
This clearance is catalogued under FDA product code ETW and 21 CFR 874.3310, within the Ear, Nose, Throat review panel as a Class II device.