Cleared Traditional

K932191 - BREATHING BAGS
(FDA 510(k) Clearance)

K932191 · Life Shield Healthcare Products, Inc. · Anesthesiology
Jul 1993
Decision
57d
Days
Class 1
Risk

K932191 is an FDA 510(k) clearance for the BREATHING BAGS, a Bag, Reservoir (Class I — General Controls, product code BTC), submitted by Life Shield Healthcare Products, Inc. (Noblesville, US). The FDA issued a Cleared decision on July 2, 1993, 57 days after receiving the submission on May 6, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5320.

Submission Details

510(k) Number K932191 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1993
Decision Date July 02, 1993
Days to Decision 57 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BTC — Bag, Reservoir
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5320