The following data is part of a premarket notification filed by Zhejiang Haisheng Medical Device Co., Ltd. with the FDA for Breathing Circuit Bacterial/viral Filter.
Device ID | K151498 |
510k Number | K151498 |
Device Name: | Breathing Circuit Bacterial/viral Filter |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. 305#TANGGONG ROAD, PAOJIANG INDUSTRIAL ZONE Shaoxing, CN 312071 |
Contact | Hu Jubin |
Correspondent | Jonathan Hu MEDWHEAT (SHANGHAI) MEDICAL TECHNOLOGY CO., LTD. YANGPU DISTRIST LIAOYUAN EAST ROAD SHUANGYANG FIRST SUITE NO.33 ROOM 303 Shanghai, CN 200093 |
Product Code | CAH |
CFR Regulation Number | 868.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-04 |
Decision Date | 2015-12-18 |
Summary: | summary |