Cleared Special

K022766 - SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER (FDA 510(k) Clearance)

Sep 2002
Decision
15d
Days
Class 2
Risk

K022766 is an FDA 510(k) clearance for the SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Siemens Medical Solutions USA, Inc. (Danvers, US). The FDA issued a Cleared decision on September 5, 2002, 15 days after receiving the submission on August 21, 2002.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K022766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2002
Decision Date September 05, 2002
Days to Decision 15 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.2700