The following data is part of a premarket notification filed by Ningbo Ranor Medical Science & Technology Co., Ltd. with the FDA for Arm Blood Pressure Monitor.
| Device ID | K193456 |
| 510k Number | K193456 |
| Device Name: | Arm Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Ningbo Ranor Medical Science & Technology Co., Ltd. No. 127 Fenghui Road, Wangchun Industrial Park, Haishu District Ningbo, CN 315000 |
| Contact | Emma Hu |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-13 |
| Decision Date | 2020-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06934832600920 | K193456 | 000 |
| 06934832600913 | K193456 | 000 |