Clearance Summary
SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE received FDA 510(k) clearance under submission number K952098, sponsored by Siemens Hearing Instruments, 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 1995-05-25.
- Submission: K952098
- Applicant / Sponsor: Siemens Hearing Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3310
- Decision date: 1995-05-25
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.