Pollenex Digital Sphygmomanometer BP-2000

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844396 ↗

FDA Product Code

DSK

Device Class

Class II

Regulation

21 CFR Part 870.1110

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K841095 Active Cleared 24 Aug 1984

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See all devices from Associated Mills, Inc. →

• What is the Pollenex Digital Sphygmomanometer BP-2000 used for?

  The Pollenex Digital Sphygmomanometer BP-2000 is a medical device specifically designed for measuring blood pressure in cardiovascular applications. It provides digital readings for accurate blood pressure monitoring.

• Is the Pollenex Digital Sphygmomanometer BP-2000 single-use or reusable?

  The BP-2000 is intended for both single-use and multiple-use applications as specified by the manufacturer. The device's usage instructions should be consulted to determine the appropriate application method for specific clinical settings.

• What regulatory approvals does the Pollenex Digital Sphygmomanometer BP-2000 have?

  The Pollenex Digital Sphygmomanometer BP-2000 received FDA 510(k) clearance on April 18, 1985. It is classified as a Class II medical device with product code DSK, indicating it meets specific regulatory requirements for safety and effectiveness.

• Who manufactures the Pollenex Digital Sphygmomanometer BP-2000?

  The Pollenex Digital Sphygmomanometer BP-2000 is manufactured by Associated Mills, Inc., a company based in Chicago, Illinois. The device was developed for cardiovascular applications and received regulatory clearance in 1985.