Cleared Traditional

K895853 - SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT
(FDA 510(k) Clearance)

K895853 · Sechrist Industries, Inc. · Anesthesiology
Dec 1989
Decision
80d
Days
Class 1
Risk

K895853 is an FDA 510(k) clearance for the SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT, a Set, Tubing And Support, Ventilator (w Harness) (Class I — General Controls, product code BZO), submitted by Sechrist Industries, Inc. (Anaheim, US). The FDA issued a Cleared decision on December 22, 1989, 80 days after receiving the submission on October 3, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5975.

Submission Details

510(k) Number K895853 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 1989
Decision Date December 22, 1989
Days to Decision 80 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BZO — Set, Tubing And Support, Ventilator (w Harness)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5975