The following data is part of a premarket notification filed by Jawon Medical Co., Ltd. with the FDA for Fuzzy Type Digital Blood Pressure Monitor, Model #'s Hd-1000s & Hd-2000f.
| Device ID | K983855 |
| 510k Number | K983855 |
| Device Name: | FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | JAWON MEDICAL CO., LTD. 1208-12 SINGSANG-LI, JINRYANG MYUN Kyungsan-city, Kungsang-bukdo, KR |
| Correspondent | Carole Stamp TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1998-11-02 |
| Decision Date | 1998-11-17 |
| Summary: | summary |