Clearance Summary
MODEL 1309 AUDIO MONITOR received FDA 510(k) clearance under submission number K790664, sponsored by Life-Tech Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1979-04-23.
- Submission: K790664
- Applicant / Sponsor: Life-Tech Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1375
- Decision date: 1979-04-23
Classification & Regulation
This clearance is catalogued under FDA product code IKN and 21 CFR 890.1375, within the Physical Medicine review panel as a Class II device.