Clearance Summary
POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000 received FDA 510(k) clearance under submission number K844396, sponsored by Associated Mills, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-04-18.
- Submission: K844396
- Applicant / Sponsor: Associated Mills, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1110
- Decision date: 1985-04-18
Classification & Regulation
This clearance is catalogued under FDA product code DSK and 21 CFR 870.1110, within the Cardiovascular review panel as a Class II device.