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Electronic Digital BP Meter HC 3001

by North American Philips Corp. 510(k)

Active United States

510(k) K842486

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK842486 Date24 Aug 1984ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Electronic Digital BP Meter HC 3001 is an electronic device that measures arterial blood pressure and displays the results digitally. It provides clinicians with systolic and diastolic pressure values using an integrated cuff and electronic sensor system.

The device was cleared by the FDA through a traditional 510(k) submission (K842486) as substantially equivalent, with product code DXN. It is manufactured by North American Philips Corp. in McHenry, Illinois, United States, and is identified by the model number HC 3001.

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