The following data is part of a premarket notification filed by K-jump Health Co., Ltd. with the FDA for Auto Digital Upper Arm Blood Pressure Monitor, Model Kp-7770.
| Device ID | K092806 |
| 510k Number | K092806 |
| Device Name: | AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | K-JUMP HEALTH CO., LTD. NO. 56, WU KUNG 5TH RD., WU KU INDUSTRIAL PARK Taipei Hsien, TW 248 |
| Contact | Jason Cheng |
| Correspondent | Jason Cheng K-JUMP HEALTH CO., LTD. NO. 56, WU KUNG 5TH RD., WU KU INDUSTRIAL PARK Taipei Hsien, TW 248 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-11 |
| Decision Date | 2009-10-09 |
| Summary: | summary |