Cleared Traditional

DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS

K921624 · Intertech Resources, Inc. · Anesthesiology
Jun 1992
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K921624 is an FDA 510(k) clearance for the DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS, a Drain, Tee (water Trap) (Class I — General Controls, product code BYH), submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on June 30, 1992, 85 days after receiving the submission on April 6, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5995.

Submission Details

510(k) Number K921624 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 1992
Decision Date June 30, 1992
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BYH — Drain, Tee (water Trap)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5995

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