Clearance Summary
PULSE CARDULE (MODEL 1859/1860 ECG) received FDA 510(k) clearance under submission number K760120, sponsored by Spacelabs, 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 1976-07-20.
- Submission: K760120
- Applicant / Sponsor: Spacelabs, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 1976-07-20
Classification & Regulation
This clearance is catalogued under FDA product code DRT and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.