Clearance Summary
ASC-950 ECG AMPLIFIER received FDA 510(k) clearance under submission number K894161, 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 1989-08-03.
- Submission: K894161
- Applicant / Sponsor: Astro-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2050
- Decision date: 1989-08-03
Classification & Regulation
This clearance is catalogued under FDA product code DRR and 21 CFR 870.2050, within the Cardiovascular review panel as a Class II device.