Clearance Summary
SNORING MICROPHONE, SM1 received FDA 510(k) clearance under submission number K940015, sponsored by Pro-Tech, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1995-01-11.
- Submission: K940015
- Applicant / Sponsor: Pro-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2375
- Decision date: 1995-01-11
Classification & Regulation
This clearance is catalogued under FDA product code MNR and 21 CFR 868.2375, within the Anesthesiology review panel as a Class II device.