510(k) K151498

Breathing circuit bacterial/viral filter by Zhejiang Haisheng Medical Device Co., Ltd. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2015
Date Received
June 4, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type