Cleared Traditional

K932584 - BREATHING BAGS
(FDA 510(k) Clearance)

K932584 · Merit Medical Systems, Inc. · Anesthesiology

Jul 1993

Decision

50d

Days

Class 1

Risk

K932584 is an FDA 510(k) clearance for the BREATHING BAGS. This device is classified as a Bag, Reservoir (Class I — General Controls, product code BTC).

Submitted by Merit Medical Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 16, 1993, 50 days after receiving the submission on May 27, 1993.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5320.

Submission Details

510(k) Number	K932584 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 1993
Decision Date	July 16, 1993
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement