The following data is part of a premarket notification filed by Conmo Electronic Company Limited with the FDA for Upper Arm Electronic Blood Pressure Monitor.
| Device ID | K202372 |
| 510k Number | K202372 |
| Device Name: | Upper Arm Electronic Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Conmo Electronic Company Limited Room 1402, Building No.10,Shenzhen Biomedicine Innovations Industrial Park, Jinhui Road No.14,Kengzi Street, Pingshan D Shenzhen City, CN 518126 |
| Contact | Alice Qi |
| Correspondent | Charlie Mack International Regulatory Consultants 2950 E Lindrick Drive Chandler, AZ 85249 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-19 |
| Decision Date | 2020-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971209160076 | K202372 | 000 |