Clearance Summary
DASH IV received FDA 510(k) clearance under submission number K912929, 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 1991-08-13.
- Submission: K912929
- Applicant / Sponsor: Astro-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.2810
- Decision date: 1991-08-13
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.