Clearance Summary
HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS. received FDA 510(k) clearance under submission number K890864, sponsored by Rastronics USA, Inc.. 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 1989-06-21.
- Submission: K890864
- Applicant / Sponsor: Rastronics USA, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1090
- Decision date: 1989-06-21
Classification & Regulation
This clearance is catalogued under FDA product code ETY and 21 CFR 874.1090, within the Ear, Nose, Throat review panel as a Class II device.