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Modified Sphygmomed Non-Invasive Blood Pres. Monit

by Draeger Medical, Inc.

510(k) K871886

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK871886 Date29 Jul 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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, 24 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 Modified Sphygmomed Non-Invasive Blood Pressure Monitor is a medical device designed to measure blood pressure without invasive procedures. It functions as a diagnostic tool for monitoring cardiovascular health in clinical settings.

This device is identified by FDA 510(k) number K871886 and has received FDA 510(k) clearance. It is manufactured by Draeger Medical, Inc. and is categorized under product code DXN.

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