The following data is part of a premarket notification filed by Jawon Medical Co., Ltd. with the FDA for Automoatic Blood Pressure Monitor, Models: Easy X 800 And 900 (r/l).
| Device ID | K092432 |
| 510k Number | K092432 |
| Device Name: | AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L) |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | JAWON MEDICAL CO., LTD. #1208-12, Sinsang-Li, Jinryang-Myun Kyungsan-city, Kyungsan-bukdo, KR 712-830 |
| Contact | H L Jung |
| Correspondent | H L Jung MI Consulting Co., Ltd. ROOM 431, LIFE OFFICETEL, 61-3 YOIDO-DONG, YOUNGDEUNGPO-GU Seoul, KR 150-731 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-07 |
| Decision Date | 2009-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08805116000317 | K092432 | 000 |
| 08805116000300 | K092432 | 000 |