Clearance Summary
MODEL 525 NEO-TRAK NEONATAL RECORDER received FDA 510(k) clearance under submission number K823210, sponsored by Ge Medical Systems Information Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1982-11-24.
- Submission: K823210
- Applicant / Sponsor: Ge Medical Systems Information Technologies
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.2810
- Decision date: 1982-11-24
Classification & Regulation
This clearance is catalogued under FDA product code DSF and 21 CFR 870.2810, within the Cardiovascular review panel as a Class I device.