Clearance Summary
PACESTART received FDA 510(k) clearance under submission number K872778, sponsored by Pacific Rim Engineering & Mfg.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1987-11-04.
- Submission: K872778
- Applicant / Sponsor: Pacific Rim Engineering & Mfg.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5550
- Decision date: 1987-11-04
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.