Clearance Summary
CRITIVIEW, MODEL CRV3 received FDA 510(k) clearance under submission number K062977, sponsored by Critisense , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-02-28.
- Submission: K062977
- Applicant / Sponsor: Critisense , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2100
- Decision date: 2007-02-28
Classification & Regulation
This clearance is catalogued under FDA product code DPW and 21 CFR 870.2100, within the Cardiovascular review panel as a Class II device.