Clearance Summary
HEARTSTREAM ELECTRODE ADAPTER received FDA 510(k) clearance under submission number K984286, sponsored by Hewlett-Packard Co.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-12-17.
- Submission: K984286
- Applicant / Sponsor: Hewlett-Packard Co.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.5310
- Decision date: 1998-12-17
Classification & Regulation
This clearance is catalogued under FDA product code MKJ and 21 CFR 870.5310, within the Cardiovascular review panel as a Class III device.