The following data is part of a premarket notification filed by Jiangxi Aicare Medical Technology Co., Ltd with the FDA for Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,x8, X11).
| Device ID | K221040 |
| 510k Number | K221040 |
| Device Name: | Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Jiangxi AICARE Medical Technology Co., Ltd No.6, South Side Of Nanhuan Road Qianping Industrial Park, Le'an Country Fuzhou, CN 344300 |
| Contact | Lizhu Xiao |
| Correspondent | Bing Huang Feiying Drug And Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, CN 518052 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-07 |
| Decision Date | 2022-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972480916383 | K221040 | 000 |
| 06972480913054 | K221040 | 000 |
| 06972480913047 | K221040 | 000 |
| 06972480913030 | K221040 | 000 |
| 06972480913023 | K221040 | 000 |
| 06972480913009 | K221040 | 000 |
| 06972480912996 | K221040 | 000 |
| 06972480913269 | K221040 | 000 |