Cleared Traditional

Breathing circuit bacterial/viral filter

K151498 · Zhejiang Haisheng Medical Device Co., Ltd. · General Hospital

Dec 2015

Decision

197d

Days

Class 2

Risk

About This 510(k) Submission

K151498 is an FDA 510(k) clearance for the Breathing circuit bacterial/viral filter, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Zhejiang Haisheng Medical Device Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on December 18, 2015, 197 days after receiving the submission on June 4, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number	K151498 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2015
Decision Date	December 18, 2015
Days to Decision	197 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF