The following data is part of a premarket notification filed by Shenzhen Ant Hi-tech Industrial Co., Ltd with the FDA for Disposable Pressure Transducer.
| Device ID | K091408 |
| 510k Number | K091408 |
| Device Name: | DISPOSABLE PRESSURE TRANSDUCER |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD SUITE 8D, ZHONGXIN ZHONGSHAN NO.19, LANE 999 ZHONGSHAN NO.2 Shanghai, CN 200030 |
| Contact | Lee Fu |
| Correspondent | Lee Fu SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD SUITE 8D, ZHONGXIN ZHONGSHAN NO.19, LANE 999 ZHONGSHAN NO.2 Shanghai, CN 200030 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-12 |
| Decision Date | 2009-08-18 |
| Summary: | summary |