The following data is part of a premarket notification filed by Jawon Medical Co., Ltd. with the FDA for Digital Blood Pressure Monitor, Models Hd-503 And Hd-505.
| Device ID | K002722 |
| 510k Number | K002722 |
| Device Name: | DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | JAWON MEDICAL CO., LTD. 7F JEONG JU BLDG. SEOCHO-DONG. SEOCHO-KU Seoul, KR 1451-38 |
| Contact | Won-hee Park |
| Correspondent | Robert Boonstra UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-08-31 |
| Decision Date | 2000-09-11 |