Cleared Traditional

S9 CRONULLA FOR HER

K132606 · Resmed, Ltd. · Anesthesiology

Jan 2014

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K132606 is an FDA 510(k) clearance for the S9 CRONULLA FOR HER, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Resmed, Ltd. (San Diego, US). The FDA issued a Cleared decision on January 13, 2014, 146 days after receiving the submission on August 20, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K132606 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 2013
Decision Date	January 13, 2014
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF