Clearance Summary
AUDIO MONITOR-MODEL 8309 received FDA 510(k) clearance under submission number K780538, sponsored by Life-Tech Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1978-04-19.
- Submission: K780538
- Applicant / Sponsor: Life-Tech Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1845
- Decision date: 1978-04-19
Classification & Regulation
This clearance is catalogued under FDA product code GWK and 21 CFR 882.1845, within the Neurology review panel as a Class II device.