The following data is part of a premarket notification filed by K-jump Health Co., Ltd. with the FDA for Arm Blood Pressure Monitor, Models Kp-6821, Kp-6822.
| Device ID | K014204 |
| 510k Number | K014204 |
| Device Name: | ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | K-JUMP HEALTH CO., LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan K-JUMP HEALTH CO., LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-21 |
| Decision Date | 2002-03-05 |
| Summary: | summary |