The following data is part of a premarket notification filed by Ya Horng Electronic Co., Ltd. with the FDA for Ya Horng Arm Type Digital Blood Pressure Monitor, Models Bp-600, Bp-600r, Bp-600u, Bp-600b, Bp-600rb, Bp-600ub, Bp-600j.
| Device ID | K081590 |
| 510k Number | K081590 |
| Device Name: | YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | YA HORNG ELECTRONIC CO., LTD. 2F, NO. 13, HUANSHAN ROAD LANE 28, SEC 1 Nei Hu, Taipei, TW 114 |
| Contact | Steven Chang |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-06-06 |
| Decision Date | 2008-06-19 |
| Summary: | summary |