Clearance Summary
DINAMAP COMPACT MONITOR received FDA 510(k) clearance under submission number K970182, sponsored by Johnson & Johnson 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 1997-08-18.
- Submission: K970182
- Applicant / Sponsor: Johnson & Johnson Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1997-08-18
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.