Clearance Summary
STONY BROOK MODEL EECP-MC1 received FDA 510(k) clearance under submission number K882401, sponsored by Stony Brook Trading and Development Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1989-03-03.
- Submission: K882401
- Applicant / Sponsor: Stony Brook Trading and Development Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5225
- Decision date: 1989-03-03
Classification & Regulation
This clearance is catalogued under FDA product code DRN and 21 CFR 870.5225, within the Cardiovascular review panel as a Class II device.