Clearance Summary
RECOMB ECG PREAMPLIFIER/206 069 03 received FDA 510(k) clearance under submission number K834600, sponsored by Litton Medical Electronics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1984-06-01.
- Submission: K834600
- Applicant / Sponsor: Litton Medical Electronics
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 1984-06-01
Classification & Regulation
This clearance is catalogued under FDA product code DRT and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.