Skip to content

Bci WW1021 Pc Application

by Smiths Medical Pm, Inc.

510(k) K090205

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 NumberK090205 Date28 Apr 2009ClearedStatusActive

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  • Withdrawn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
DQA
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 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 WW1021 PC Application is software designed to connect with compatible oximeters via a USB port. It enables the real-time viewing, downloading, analysis, and printing of recorded data and supports sleep screening functions.

This application is intended for use with devices that support the BCI Communication Protocol 1030. It is operated by healthcare professionals, including physicians, respiratory therapists, nurses, and sleep technicians, within hospital and clinical environments. The device has received FDA 510(k) clearance.

Other devices from Smiths Medical Pm, Inc.