The following data is part of a premarket notification filed by Mars Metal Co., Ltd. with the FDA for Mars Digital Blood Pressure Monitor.
| Device ID | K945215 |
| 510k Number | K945215 |
| Device Name: | MARS DIGITAL BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MARS METAL CO., LTD. 5510 SUGAR PINE DR. Yorba Linda, CA 92686 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-25 |
| Decision Date | 1996-01-31 |