Cleared Traditional

HRI 6500, 6600 AND 6700 SERIES V2MASKS

K071149 · Hans Rudolph, Inc. · Anesthesiology
Feb 2008
Decision
283d
Days
Class 2
Risk

About This 510(k) Submission

K071149 is an FDA 510(k) clearance for the HRI 6500, 6600 AND 6700 SERIES V2MASKS, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Hans Rudolph, Inc. (Kansas City, US). The FDA issued a Cleared decision on February 1, 2008, 283 days after receiving the submission on April 24, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K071149 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2007
Decision Date February 01, 2008
Days to Decision 283 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

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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