Cleared Traditional

THE INFANT FLOW SYSTEM

K930713 · Sechrist Industries, Inc. · Anesthesiology
Sep 1993
Decision
217d
Days
Class 1
Risk

About This 510(k) Submission

K930713 is an FDA 510(k) clearance for the THE INFANT FLOW SYSTEM, a Circuit, Breathing (w Connector, Adaptor, Y Piece) (Class I — General Controls, product code CAI), submitted by Sechrist Industries, Inc. (Anaheim, US). The FDA issued a Cleared decision on September 16, 1993, 217 days after receiving the submission on February 11, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5240.

Submission Details

510(k) Number K930713 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 1993
Decision Date September 16, 1993
Days to Decision 217 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CAI — Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5240

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