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BCI Model 6004 NIBP Monitor (6004)

by Bci Intl., Inc.

510(k) K970801

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK970801 Date12 Nov 1997ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1649-2008 FDA Unclassified (pre-2012) initiated 2 Apr 2008

    Due to a component that may be installed backwards, the device may turn off or may immediately reset.

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  • Withdrawn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 BCI Model 6004 NIBP Monitor (6004) is a portable, tabletop device for non-invasive blood pressure (NIBP) monitoring with optional pulse oximetry (SpO2) capability. It processes NIBP cuff pressure signals and SpO2 probe optical signals to calculate systolic, diastolic, mean arterial pressure, pulse rate, and SpO2 levels.

The device is supplied as a reusable monitor intended for use in clinical settings. It received on March 4, 1997, and received a substantially equivalent decision on November 12, 1997, under the FDA 510(k) pathway with K number K970801 and product code DXN.

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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 BCI Model 6004 NIBP Monitor used for?

    The BCI Model 6004 NIBP Monitor is used for non-invasive blood pressure monitoring in clinical settings, measuring systolic, diastolic, mean arterial pressure, and pulse rate from cuff pressure signals, with optional SpO2 capability to calculate oxygen saturation from probe optical signals.

  • Is the BCI Model 6004 NIBP Monitor reusable or single-use?

    The BCI Model 6004 NIBP Monitor is supplied as a reusable monitor, meaning it is designed for repeated use in clinical environments after appropriate cleaning and maintenance, not for single-patient disposal.

  • What are the key specifications and regulatory details of the BCI Model 6004 NIBP Monitor?

    The device is a portable tabletop NIBP monitor with optional SpO2, received on March 4, 1997, and granted a substantially equivalent decision on November 12, 1997, under FDA 510(k) K970801 with product code DXN, classified under cardiovascular advisory committee review.