The following data is part of a premarket notification filed by Truly Instrument Co., Ltd. with the FDA for Truly Automatic Arm Blood Pressure Monitordb21,db31,db22,db23,db71m,db32,db61m, Db62m, Db63m.
| Device ID | K091434 |
| 510k Number | K091434 |
| Device Name: | TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | TRULY INSTRUMENT CO., LTD. TRULY INDUSTRICAL AREA Shanwei Shi, Guang Dong, CN 516600 |
| Contact | Yangjian Hao |
| Correspondent | Yangjian 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 |