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 |