Clearance Summary
PASSPORT V MONITOR, MODEL 0998-00-6100 received FDA 510(k) clearance under submission number K091834, sponsored by Datascope Corp., Patient Monitoring Division. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2009-07-15.
- Submission: K091834
- Applicant / Sponsor: Datascope Corp., Patient Monitoring Division
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2009-07-15
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.