Clearance Summary
OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM received FDA 510(k) clearance under submission number K971840, sponsored by Invivo Research, 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 1998-03-04.
- Submission: K971840
- Applicant / Sponsor: Invivo Research, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1998-03-04
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.