Clearance Summary
ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II received FDA 510(k) clearance under submission number K053006, sponsored by Rossmax Internationl , 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 2006-02-03.
- Submission: K053006
- Applicant / Sponsor: Rossmax Internationl , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 2006-02-03
Classification & Regulation
This clearance is catalogued under FDA product code DXQ and 21 CFR 870.1120, within the Cardiovascular review panel as a Class II device.