Clearance Summary
RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE received FDA 510(k) clearance under submission number K850365, sponsored by Eaton Medical Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-04-09.
- Submission: K850365
- Applicant / Sponsor: Eaton Medical Group
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.2810
- Decision date: 1985-04-09
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.