The following data is part of a premarket notification filed by Jawon Medical Co., Ltd. with the FDA for Wrist Type Digital Blood Pressure Monitor, Model Hd-303s.
| Device ID | K991688 |
| 510k Number | K991688 |
| Device Name: | WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | JAWON MEDICAL CO., LTD. 222 INSTITUTE ST. Smithfield, VA 23430 |
| Contact | Robert D Waxham |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-05-17 |
| Decision Date | 1999-06-01 |
| Summary: | summary |