Clearance Summary
ELECTRODE IMPEDANCE TESTER-MODEL 500 received FDA 510(k) clearance under submission number K781475, 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 1978-09-07.
- Submission: K781475
- Applicant / Sponsor: Life-Tech Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1410
- Decision date: 1978-09-07
Classification & Regulation
This clearance is catalogued under FDA product code GYA and 21 CFR 882.1410, within the Neurology review panel as a Class I device.