Cleared Traditional

BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE

K091461 · Cardiopulmonary Corp. · Anesthesiology
Aug 2009
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K091461 is an FDA 510(k) clearance for the BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE, 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 August 14, 2009, 88 days after receiving the submission on May 18, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K091461 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2009
Decision Date August 14, 2009
Days to Decision 88 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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