Cleared Traditional

ONE-WAY VALVE (WITH CONNECTOR)

K970780 · Instrumentation Industries, Inc. · Anesthesiology
Sep 1997
Decision
198d
Days
Class 2
Risk

About This 510(k) Submission

K970780 is an FDA 510(k) clearance for the ONE-WAY VALVE (WITH CONNECTOR), 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 September 18, 1997, 198 days after receiving the submission on March 4, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5870.

Submission Details

510(k) Number K970780 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 1997
Decision Date September 18, 1997
Days to Decision 198 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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