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NIBP 9225 Combi

by S & W Medico Teknik

510(k) K912815

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 NumberK912815 Date9 Oct 1992ClearedStatusActive

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  • Withdrawn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, 22 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 NIBP 9225 Combi is a device used for non-invasive blood pressure monitoring. It is classified as a Cardiovascular device with a product code of DXN.

The device is supplied by S & W Medico Teknik and has received FDA 510K authorization. It is a Class 2 device with a traditional clearance type, and its regulation number is 870.1130. The device was substantially equivalent and received clearance on October 9, 1992.

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Questions

AI-generated answers, 22 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 NIBP 9225 Combi used for?

    The NIBP 9225 Combi is used for non-invasive blood pressure monitoring, specifically for cardiovascular applications.

  • Is the NIBP 9225 Combi a single-use or reusable device?

    The device data does not specify whether the NIBP 9225 Combi is single-use or reusable, but it is classified as a Class 2 device.

  • What is the regulatory status of the NIBP 9225 Combi?

    The NIBP 9225 Combi has received FDA 510K authorization, indicating that it is substantially equivalent to a predicate device.

  • Who is the manufacturer of the NIBP 9225 Combi?

    The NIBP 9225 Combi is manufactured by S & W Medico Teknik, with headquarters in Denmark.