The following data is part of a premarket notification filed by King Yield Hongkong Limited with the FDA for Bp 101 Digital Blood Pressure Monitor.
| Device ID | K062033 |
| 510k Number | K062033 |
| Device Name: | BP 101 DIGITAL BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | KING YIELD HONGKONG LIMITED 12 FL, NO. 180 ELECTRIC ROAD North Point, HK |
| Contact | Dacheng Gong |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-07-18 |
| Decision Date | 2007-03-23 |
| Summary: | summary |