Clearance Summary
PHYSICAL MONITORING REGISTRATION UNIT received FDA 510(k) clearance under submission number K022719, sponsored by Maryrose Cusimano, Ph.D./Phil Reaston. 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 2002-11-13.
- Submission: K022719
- Applicant / Sponsor: Maryrose Cusimano, Ph.D./Phil Reaston
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1375
- Decision date: 2002-11-13
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.