The following data is part of a premarket notification filed by Truly Instrument Limited with the FDA for Automatic Arm Bluetooth Blood Pressure Monitor.
| Device ID | K161846 |
| 510k Number | K161846 |
| Device Name: | Automatic Arm Bluetooth Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | TRULY INSTRUMENT LIMITED SITE 2, TRULY INDUSTRY AREA Shanwei, CN 516600 |
| Contact | Yang Jian-ho |
| Correspondent | Max Wong TRULY (U.S.A) INC 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 | 2016-07-05 |
| Decision Date | 2016-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34719878120037 | K161846 | 000 |