Clearance Summary
ARRHYTHMIA PROGRAM MODULE received FDA 510(k) clearance under submission number K780432, sponsored by Midwest Analog & Digital, 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 1978-05-26.
- Submission: K780432
- Applicant / Sponsor: Midwest Analog & Digital, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1978-05-26
Classification & Regulation
This clearance is catalogued under FDA product code DSI and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.