Cleared Traditional

NON-REBREATHING 'T' (BE 117)

K973066 · Instrumentation Industries, Inc. · Anesthesiology
Feb 1998
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K973066 is an FDA 510(k) clearance for the NON-REBREATHING 'T' (BE 117), 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 February 3, 1998, 169 days after receiving the submission on August 18, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5870.

Submission Details

510(k) Number K973066 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1997
Decision Date February 03, 1998
Days to Decision 169 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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