Clearance Summary
GALIX MA-6C HOLTER CASSETTE RECORDER received FDA 510(k) clearance under submission number K904177, sponsored by Galix Instrumentacion Biomedica. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1991-09-20.
- Submission: K904177
- Applicant / Sponsor: Galix Instrumentacion Biomedica
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 1991-09-20
Classification & Regulation
This clearance is catalogued under FDA product code DSH and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.