Cleared Special

BREEZE SLEEPGEAR WITH DREAMSEAL

K002001 · Puritan Bennett Corp. · Anesthesiology
Sep 2000
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K002001 is an FDA 510(k) clearance for the BREEZE SLEEPGEAR WITH DREAMSEAL, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Puritan Bennett Corp. (Minneapolis, US). The FDA issued a Cleared decision on September 6, 2000, 68 days after receiving the submission on June 30, 2000. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K002001 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2000
Decision Date September 06, 2000
Days to Decision 68 days
Submission Type Special
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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