The following data is part of a premarket notification filed by Shenzhen Jamr Technology Co., Ltd. with the FDA for Blood Pressure Monitor.
| Device ID | K200437 |
| 510k Number | K200437 |
| Device Name: | Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen Jamr Technology Co., Ltd. 2nd Floor, A-building, No.2 Guiyuan Road, Guihua Community, Guanlan Town Shenzhen, CN 518110 |
| Contact | Luo Fusheng |
| Correspondent | Luo Fusheng Shenzhen Jamr Technology Co., Ltd. 2nd Floor, A-building, No.2 Guiyuan Road, Guihua Community, Guanlan Town Shenzhen, CN 518110 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-24 |
| Decision Date | 2020-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16927709414017 | K200437 | 000 |
| 10856471007324 | K200437 | 000 |
| 10856471007317 | K200437 | 000 |
| 16927709465101 | K200437 | 000 |
| 16927709402441 | K200437 | 000 |
| 16927709402465 | K200437 | 000 |
| 16927709421039 | K200437 | 000 |
| 16927709415168 | K200437 | 000 |
| 16927709466030 | K200437 | 000 |
| 16927709426232 | K200437 | 000 |
| 16927709423101 | K200437 | 000 |
| 06927709423111 | K200437 | 000 |
| 00856324008723 | K200437 | 000 |
| 00856324008730 | K200437 | 000 |
| 10370393005188 | K200437 | 000 |
| 16927709486014 | K200437 | 000 |
| 16927709486038 | K200437 | 000 |
| 16927709486045 | K200437 | 000 |
| 06927709421025 | K200437 | 000 |
| 16927709486021 | K200437 | 000 |
| 00856324008693 | K200437 | 000 |
| 16927709415144 | K200437 | 000 |
| 16927709415137 | K200437 | 000 |
| 16927709426225 | K200437 | 000 |
| 16927709426218 | K200437 | 000 |
| 06927709486055 | K200437 | 000 |