The following data is part of a premarket notification filed by Zen Strong Medical Technology Co., Ltd with the FDA for Blood Pressure Monitor, Models Zsbp-oxx And Zsbp-1xx.
| Device ID | K070473 |
| 510k Number | K070473 |
| Device Name: | BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ZEN STRONG MEDICAL TECHNOLOGY CO., LTD 6F,NO.88 NING JING ST., Keelung,, TW |
| Contact | Cheng Roei-sheng |
| Correspondent | Cheng Roei-sheng ZEN STRONG MEDICAL TECHNOLOGY CO., LTD 6F,NO.88 NING JING ST., Keelung,, TW |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-20 |
| Decision Date | 2007-05-23 |
| Summary: | summary |