The following data is part of a premarket notification filed by Jawon Medical Co., Ltd. with the FDA for Automatic Blood Pressure Monitor.
| Device ID | K140762 |
| 510k Number | K140762 |
| Device Name: | AUTOMATIC BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | JAWON MEDICAL CO., LTD. 1208-12 SINGSANG-RI, JINRYANG-EUP Kyungsan-city, Kyungsang-bukdo, KR 712-830 |
| Contact | Woo Park |
| Correspondent | Woo Park MEDMONTS CO., LTD LIFE-OFFICETEL 320,40,63-RO YOUNGDEUNGPO-GU Seoul, KR 150-731 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-27 |
| Decision Date | 2015-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08805116000379 | K140762 | 000 |