Clearance Summary
MONITOR, GSR (NB-401) received FDA 510(k) clearance under submission number K760084, sponsored by Narco Bio-Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1976-07-26.
- Submission: K760084
- Applicant / Sponsor: Narco Bio-Systems
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 1976-07-26
Classification & Regulation
This clearance is catalogued under FDA product code HCC and 21 CFR 882.5050, within the Neurology review panel as a Class II device.