Clearance Summary
COMBINED PHYSIOLOGICAL MONITORING SYSTEM received FDA 510(k) clearance under submission number K002104, sponsored by Maryrose Cusimano, Ph.D. & Scott Zeff. 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 2000-10-10.
- Submission: K002104
- Applicant / Sponsor: Maryrose Cusimano, Ph.D. & Scott Zeff
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1375
- Decision date: 2000-10-10
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.