Cleared Traditional

IISIS, VERSION 1.0

K052244 · Innovision Medical Technologies, LLC · Anesthesiology

Oct 2005

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K052244 is an FDA 510(k) clearance for the IISIS, VERSION 1.0, a Accessory To Continuous Ventilator (respirator) (Class II — Special Controls, product code MOD), submitted by Innovision Medical Technologies, LLC (Linthicum, US). The FDA issued a Cleared decision on October 13, 2005, 57 days after receiving the submission on August 17, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number	K052244 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 17, 2005
Decision Date	October 13, 2005
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF