Cleared Special

K111148 - S8 ASPEN WITH H4I PLUS
(FDA 510(k) Clearance)

K111148 · ResMed Corp · Anesthesiology

Jun 2011

Decision

69d

Days

Class 2

Risk

K111148 is an FDA 510(k) clearance for the S8 ASPEN WITH H4I PLUS, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by ResMed Corp (San Diego, US). The FDA issued a Cleared decision on June 30, 2011, 69 days after receiving the submission on April 22, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K111148 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2011
Decision Date	June 30, 2011
Days to Decision	69 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF