Clearance Summary
PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT received FDA 510(k) clearance under submission number K884421, sponsored by Pymah Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1989-01-13.
- Submission: K884421
- Applicant / Sponsor: Pymah Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 1989-01-13
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.