Cleared Traditional

K932563 - VENTILATOR HOSES
(FDA 510(k) Clearance)

K932563 · Life Shield Healthcare Products, Inc. · Anesthesiology device

Jul 1993

Decision

50d

Days

Class 1

Risk

K932563 is an FDA 510(k) clearance for the VENTILATOR HOSES. This device is classified as a Set, Tubing And Support, Ventilator (w Harness) (Class I - General Controls, product code BZO).

Submitted by Life Shield Healthcare Products, Inc. (Noblesville, 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 868.5975.

Submission Details

510(k) Number	K932563 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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