The following data is part of a premarket notification filed by Zen Strong Medical Technology Co., Ltd with the FDA for Blood Pressure Monitor, Zsbp-003/004/005/006/007/008 And Zsbp-102/103/104/105/106/107.
| Device ID | K090027 |
| 510k Number | K090027 |
| Device Name: | BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/107 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ZEN STRONG MEDICAL TECHNOLOGY CO., LTD 6F,NO.88 NING JIN ST. NUANNUAN DISTRICT Keelung City, TW 20542 |
| Contact | Cheng Roie-sheng |
| Correspondent | Cheng Roie-sheng ZEN STRONG MEDICAL TECHNOLOGY CO., LTD 6F,NO.88 NING JIN ST. NUANNUAN DISTRICT Keelung City, TW 20542 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-05 |
| Decision Date | 2009-02-02 |
| Summary: | summary |