Cleared Traditional

Puritan Bennett 980 Series Ventilator System

K193056 · Covidien, LLC · Anesthesiology
Nov 2020
Decision
385d
Days
Class 2
Risk

About This 510(k) Submission

K193056 is an FDA 510(k) clearance for the Puritan Bennett 980 Series Ventilator System, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on November 20, 2020, 385 days after receiving the submission on November 1, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K193056 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2019
Decision Date November 20, 2020
Days to Decision 385 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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