Skip to content

Arteriosonde Blood Press. Mntr. (#1020)

by Roche Medical Electronics, Inc.

510(k) K761057

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 NumberK761057 Date9 Dec 1976ClearedStatusActive

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  • Withdrawn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, 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 Arteriosonde Blood Pressure Monitor (#1020) is a non-invasive medical device designed to measure blood pressure. It is classified under the System, Measurement, Blood-Pressure, Non-Invasive category and falls under the Cardiovascular medical specialty.

The device is supplied as a single-use unit and is intended for use in clinical settings. It is not sterilized and requires proper storage conditions. The device is regulated under FDA 510(k) clearance (K761057) and has been reviewed by the Cardiovascular Advisory Committee.

Other devices from Roche Medical Electronics, Inc.

See all devices from Roche Medical Electronics, Inc. →

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 Arteriosonde Blood Pressure Monitor (#1020) used for?

    The Arteriosonde Blood Pressure Monitor (#1020) is a non-invasive medical device designed to measure blood pressure in clinical settings.

  • Is the Arteriosonde Blood Pressure Monitor (#1020) sterile?

    No, the device is not sterilized and requires proper storage conditions before use.

  • Is the Arteriosonde Blood Pressure Monitor (#1020) intended for single use?

    Yes, the device is supplied as a single-use unit and is intended for use in clinical settings.

  • How is the Arteriosonde Blood Pressure Monitor (#1020) regulated?

    The device is regulated under FDA 510(k) clearance (K761057) and has been reviewed by the Cardiovascular Advisory Committee.