Cleared Traditional

WHISTLER IN-LINE PRESSURE RELEASE VALVE

K831246 · Airlife, Inc. · Anesthesiology
Jul 1983
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K831246 is an FDA 510(k) clearance for the WHISTLER IN-LINE PRESSURE RELEASE VALVE, a Valve, Non-rebreathing (Class II — Special Controls, product code CBP), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1983, 99 days after receiving the submission on April 18, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5870.

Submission Details

510(k) Number K831246 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 1983
Decision Date July 26, 1983
Days to Decision 99 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CBP — Valve, Non-rebreathing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5870

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