Clearance Summary
HEART-ALERT received FDA 510(k) clearance under submission number K820444, sponsored by Medical Equipment Devices, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1982-03-12.
- Submission: K820444
- Applicant / Sponsor: Medical Equipment Devices, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.1575
- Decision date: 1982-03-12
Classification & Regulation
This clearance is catalogued under FDA product code KHX and 21 CFR 890.1575, within the Physical Medicine review panel as a Class I device.