Cleared Traditional

731 Series Ventilator

K233486 · ZOLL Medical Corporation · Anesthesiology
Dec 2024
Decision
413d
Days
Class 2
Risk

About This 510(k) Submission

K233486 is an FDA 510(k) clearance for the 731 Series Ventilator, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by ZOLL Medical Corporation (Chelmsford, US). The FDA issued a Cleared decision on December 13, 2024, 413 days after receiving the submission on October 27, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K233486 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 2023
Decision Date December 13, 2024
Days to Decision 413 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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