The following data is part of a premarket notification filed by K-jump Health Co., Ltd. with the FDA for Smart-logic Auto Digital Upperarm Blood Pressure Monitor, Model Kp-7500, Fully Fuzzy Auto Digital Upper Arm Blood Pressu.
| Device ID | K083753 |
| 510k Number | K083753 |
| Device Name: | SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-17 |
| Decision Date | 2009-06-19 |
| Summary: | summary |