The following data is part of a premarket notification filed by Zhejiang Haisheng Medical Device Co., Ltd. with the FDA for Disposable Pressure Transducer.
| Device ID | K152472 |
| 510k Number | K152472 |
| Device Name: | Disposable Pressure Transducer |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. 305#TANGGONG ROAD, PAOJIANG INDUSTRIAL ZONE Shaoxing, CN 312071 |
| Contact | Junbin Hu |
| 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 | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-31 |
| Decision Date | 2016-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945664877367 | K152472 | 000 |
| 06936735471836 | K152472 | 000 |
| 06936735471935 | K152472 | 000 |
| 06936735487271 | K152472 | 000 |
| 06936735470037 | K152472 | 000 |
| 06945664898034 | K152472 | 000 |
| 06945664879255 | K152472 | 000 |
| 06945664878784 | K152472 | 000 |
| 06945664878432 | K152472 | 000 |
| 06945664863636 | K152472 | 000 |
| 06945664863643 | K152472 | 000 |
| 06945664877947 | K152472 | 000 |
| 06945664877701 | K152472 | 000 |
| 06945664877565 | K152472 | 000 |
| 06945664877442 | K152472 | 000 |
| 06945664877381 | K152472 | 000 |
| 06936735487714 | K152472 | 000 |