The following data is part of a premarket notification filed by Truly Instrument Co., Ltd. with the FDA for Truly Automatic Arm Blood Pressure Monitor.
| Device ID | K113083 |
| 510k Number | K113083 |
| Device Name: | TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | TRULY INSTRUMENT CO., LTD. 2620 CONCORD AVENUE SUITE 106 Alhambra, CA 91803 |
| Contact | Max Wong |
| Correspondent | Max Wong TRULY INSTRUMENT CO., LTD. 2620 CONCORD AVENUE SUITE 106 Alhambra, CA 91803 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-18 |
| Decision Date | 2012-01-19 |
| Summary: | summary |