Cleared Traditional

K923444 - SERVO GRAPHICS (FDA 510(k) Clearance)

Mar 1993
Decision
235d
Days
Class 2
Risk

K923444 is an FDA 510(k) clearance for the SERVO GRAPHICS. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on March 5, 1993, 235 days after receiving the submission on July 13, 1992.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K923444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1992
Decision Date March 05, 1993
Days to Decision 235 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II - Special Controls
CFR Regulation 21 CFR 868.5895

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