Cleared Traditional

K942572 - VOLUME VENTILATOR
(FDA 510(k) Clearance)

K942572 · Med-Plastics Intl., Inc. · Anesthesiology device

Jun 1994

Decision

10d

Days

Class 1

Risk

K942572 is an FDA 510(k) clearance for the VOLUME VENTILATOR. This device is classified as a Set, Tubing And Support, Ventilator (w Harness) (Class I - General Controls, product code BZO).

Submitted by Med-Plastics Intl., Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 10, 1994, 10 days after receiving the submission on May 31, 1994.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5975.

Submission Details

510(k) Number	K942572 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 31, 1994
Decision Date	June 10, 1994
Days to Decision	10 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement