Clearance Summary
PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE received FDA 510(k) clearance under submission number K971708, sponsored by J & J Engineering, 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 1998-02-18.
- Submission: K971708
- Applicant / Sponsor: J & J Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 1998-02-18
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.