Cleared Traditional

PURITAN-BENNETT COMPANION 320 I/E

K934804 · Puritan Bennett Corp. · Anesthesiology
Feb 1995
Decision
508d
Days
Class 2
Risk

About This 510(k) Submission

K934804 is an FDA 510(k) clearance for the PURITAN-BENNETT COMPANION 320 I/E, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Puritan Bennett Corp. (Lenexa, US). The FDA issued a Cleared decision on February 27, 1995, 508 days after receiving the submission on October 7, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K934804 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1993
Decision Date February 27, 1995
Days to Decision 508 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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