Cleared Traditional

HYGROSTER

K941585 · Mallinckrodt Medical · Anesthesiology
Apr 1994
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K941585 is an FDA 510(k) clearance for the HYGROSTER, a Condenser, Heat And Moisture (artificial Nose) (Class I — General Controls, product code BYD), submitted by Mallinckrodt Medical (Argyle, US). The FDA issued a Cleared decision on April 19, 1994, 19 days after receiving the submission on March 31, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5375.

Submission Details

510(k) Number K941585 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1994
Decision Date April 19, 1994
Days to Decision 19 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BYD — Condenser, Heat And Moisture (artificial Nose)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5375

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