Cleared Traditional

BERNOULLI VENTILATOR MANAGEMENT SYSTEM

K011861 · Cardiopulmonary Corp. · Anesthesiology
Nov 2001
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K011861 is an FDA 510(k) clearance for the BERNOULLI VENTILATOR MANAGEMENT SYSTEM, a Accessory To Continuous Ventilator (respirator) (Class II — Special Controls, product code MOD), submitted by Cardiopulmonary Corp. (Milford, US). The FDA issued a Cleared decision on November 6, 2001, 145 days after receiving the submission on June 14, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K011861 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2001
Decision Date November 06, 2001
Days to Decision 145 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code MOD — Accessory To Continuous Ventilator (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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