Clearance Summary
SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION received FDA 510(k) clearance under submission number K962970, sponsored by Spacelabs Medical, 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 1997-03-25.
- Submission: K962970
- Applicant / Sponsor: Spacelabs Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1997-03-25
Classification & Regulation
This clearance is catalogued under FDA product code DSI and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.