The following data is part of a premarket notification filed by Jawon Medical Co., Ltd. with the FDA for Non-invasive Blood Pressure Monitor, Models Ft-500r/l And Ft-700r/l.
| Device ID | K062462 |
| 510k Number | K062462 |
| Device Name: | NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | JAWON MEDICAL CO., LTD. 13 LOT, 21 BLOCK, JIN-RYANG INDUSTRIAL COMPLEX Kyung-sun, Kyung-buk, KR 713830 |
| Contact | W. H Park |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-08-24 |
| Decision Date | 2006-09-29 |
| Summary: | summary |