The following data is part of a premarket notification filed by Tung Fu Electric Co., Ltd. with the FDA for Tf-bp01 Blood Pressure Measurement System.
| Device ID | K061452 |
| 510k Number | K061452 |
| Device Name: | TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | TUNG FU ELECTRIC CO., LTD. 4F, NO. 88, SEC. 1 KWANG FU ROAD San Chung, TW 241 |
| Contact | Shu-mei Wu |
| Correspondent | Shu-mei Wu TUNG FU ELECTRIC CO., LTD. 4F, NO. 88, SEC. 1 KWANG FU ROAD San Chung, TW 241 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-25 |
| Decision Date | 2006-07-12 |
| Summary: | summary |