Clearance Summary
DINAMAP MPS PORTABLE MONITOR received FDA 510(k) clearance under submission number K971569, 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 1997-09-19.
- Submission: K971569
- Applicant / Sponsor: Johnson & Johnson Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 1997-09-19
Classification & Regulation
This clearance is catalogued under FDA product code MSX and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.