Clearance Summary
MT9000 CHART RECORDER received FDA 510(k) clearance under submission number K892067, sponsored by Astro-Med, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1989-06-05.
- Submission: K892067
- Applicant / Sponsor: Astro-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 1989-06-05
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.