Cleared Traditional

FLEXLIFE

K952036 · Mallinckrodt Medical · Anesthesiology
Jun 1995
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K952036 is an FDA 510(k) clearance for the FLEXLIFE, a Condenser, Heat And Moisture (artificial Nose) (Class I — General Controls, product code BYD), submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on June 8, 1995, 38 days after receiving the submission on May 1, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5375.

Submission Details

510(k) Number K952036 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1995
Decision Date June 08, 1995
Days to Decision 38 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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