Clearance Summary
MODEL 535 NEO-TRAK RECORDER received FDA 510(k) clearance under submission number K855045, 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 1986-05-16.
- Submission: K855045
- 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: 1986-05-16
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.