Clearance Summary
NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 received FDA 510(k) clearance under submission number K971803, sponsored by Neurotronics, 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 1997-11-12.
- Submission: K971803
- Applicant / Sponsor: Neurotronics, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2375
- Decision date: 1997-11-12
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.