The following data is part of a premarket notification filed by Truly Instrument Co., Ltd. with the FDA for Truly Automatic Wrist Blood Pressure Monitor, Model Dw100,dw200, Dw500,dw700,dw703,dw701m.702m.
| Device ID | K091415 |
| 510k Number | K091415 |
| Device Name: | TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | TRULY INSTRUMENT CO., LTD. TRULY INDUSTRICAL AREA Shanwei Shi, Guang Dong, CN 516600 |
| Contact | Yang Jian-hao |
| Correspondent | Yang Jian-hao TRULY INSTRUMENT CO., LTD. TRULY INDUSTRICAL AREA Shanwei Shi, Guang Dong, CN 516600 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-13 |
| Decision Date | 2009-09-04 |
| Summary: | summary |