The following data is part of a premarket notification filed by Thermor Ltd. with the FDA for Compact Digital Blood Pressure Monitor.
| Device ID | K122810 |
| 510k Number | K122810 |
| Device Name: | COMPACT DIGITAL BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | THERMOR LTD. 16975 LESLIE ST. Newmarket, CA L3y 9a1 |
| Contact | Mark Beaton |
| Correspondent | Mark Beaton THERMOR LTD. 16975 LESLIE ST. Newmarket, CA L3y 9a1 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-13 |
| Decision Date | 2013-02-08 |
| Summary: | summary |