Clearance Summary
RAYDEN MEDICAL MINI PULSE VOLUME RECORD received FDA 510(k) clearance under submission number K833155, sponsored by Burditt & Calkins-Siemens-Elema. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1984-01-26.
- Submission: K833155
- Applicant / Sponsor: Burditt & Calkins-Siemens-Elema
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 1984-01-26
Classification & Regulation
This clearance is catalogued under FDA product code DSB and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.