Cleared Traditional

731 Series Ventilators

K162832 · ZOLL Medical Corporation · Anesthesiology
Aug 2017
Decision
295d
Days
Class 2
Risk

About This 510(k) Submission

K162832 is an FDA 510(k) clearance for the 731 Series Ventilators, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by ZOLL Medical Corporation (Chelsmford, US). The FDA issued a Cleared decision on August 2, 2017, 295 days after receiving the submission on October 11, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K162832 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 2016
Decision Date August 02, 2017
Days to Decision 295 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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