The following data is part of a premarket notification filed by Portal 724, Llc with the FDA for Upper Arm Blood Pressure Monitor.
| Device ID | K163473 |
| 510k Number | K163473 |
| Device Name: | Upper Arm Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Portal 724, LLC 275 Hartz Way Suite 105 Secaucus, NJ 07094 |
| Contact | George Oneid |
| Correspondent | Jet Li Guangzhou LETA Testing Technology Co., Ltd 6F, No. 1 Tian Tai Road, Science City Luogang District Guangzhou, CN |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-12 |
| Decision Date | 2017-08-29 |