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Norelco Electronic Analog Blood Press

by North American Philips Corp. 510(k)

Active United States

510(k) K830687

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830687 Date18 May 1983ClearedStatusActive

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  • Withdrawn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, 26 Sep 2026

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

The Norelco Electronic Analog Blood Press is a noninvasive blood pressure measurement system that provides a signal from which systolic, diastolic, mean, or any combination of the three can be derived. It is classified under product code DXN and falls within the cardiovascular medical specialty as determined by the FDA advisory committee review.

This device received traditional 510(k) clearance (K830687) from the FDA on May 18, 1983, following submission by North American Philips Corp. on March 4, 1983. It was found substantially equivalent to a predicate device and is regulated as a Class II medical device. The device is manufactured by North American Philips Corp. and is identified by the model designation Norelco Electronic Analog Blood Press.

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Questions

AI-generated answers, 26 Sep 2026

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

  • What is the Norelco Electronic Analog Blood Press used for?

    The Norelco Electronic Analog Blood Press is a noninvasive blood pressure measurement system designed to provide a signal from which systolic, diastolic, mean, or any combination of the three blood pressure values can be derived for cardiovascular assessment.

  • How is the Norelco Electronic Analog Blood Press supplied and identified?

    The device is supplied as a standalone noninvasive blood pressure monitor under the model designation 'Norelco Electronic Analog Blood Press' and is manufactured by North American Philips Corp., with no indication of disposable components or single-use accessories in the provided data.

  • What regulatory pathway was used for the Norelco Electronic Analog Blood Press?

    The device received traditional 510(k) clearance (K830687) from the FDA on May 18, 1983, after being found substantially equivalent to a predicate device, and is regulated as a Class II medical device under product code DXN.