Clearance Summary
SCOLE 300 ECG RECORDER received FDA 510(k) clearance under submission number K923664, sponsored by Scole Engineering Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1994-01-13.
- Submission: K923664
- Applicant / Sponsor: Scole Engineering Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 1994-01-13
Classification & Regulation
This clearance is catalogued under FDA product code DSH and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.