Cleared Traditional

EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)

K980725 · Instrumentation Industries, Inc. · Anesthesiology
Aug 1998
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K980725 is an FDA 510(k) clearance for the EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A), a Valve, Non-rebreathing (Class II — Special Controls, product code CBP), submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on August 24, 1998, 181 days after receiving the submission on February 24, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5870.

Submission Details

510(k) Number K980725 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 1998
Decision Date August 24, 1998
Days to Decision 181 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

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

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