Clearance Summary
R2 PACE ADAPTOR CABLE, MODEL 196 received FDA 510(k) clearance under submission number K895728, sponsored by Darox 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 1989-10-12.
- Submission: K895728
- Applicant / Sponsor: Darox Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5550
- Decision date: 1989-10-12
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.