Clearance Summary
DCI MODEL EP-2 CLINICAL STIMULATOR received FDA 510(k) clearance under submission number K854196, sponsored by Digital Cardiovascular Instruments, 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 1986-05-01.
- Submission: K854196
- Applicant / Sponsor: Digital Cardiovascular Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5550
- Decision date: 1986-05-01
Classification & Regulation
This clearance is catalogued under FDA product code DRO and 21 CFR 870.5550, within the Cardiovascular review panel as a Class II device.