Clearance Summary
VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 received FDA 510(k) clearance under submission number K030613, sponsored by Criticare Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-04-17.
- Submission: K030613
- Applicant / Sponsor: Criticare Systems, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2003-04-17
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.