The following data is part of a premarket notification filed by Mirador Biomedical with the FDA for Compass Ct, Compass Ct Port.
| Device ID | K133624 |
| 510k Number | K133624 |
| Device Name: | COMPASS CT, COMPASS CT PORT |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | MIRADOR BIOMEDICAL 2815 EASTLAKE AVE E SUITE 220 Seattle, WA 98102 |
| Contact | Justin Hulvershorn |
| Correspondent | Justin Hulvershorn MIRADOR BIOMEDICAL 2815 EASTLAKE AVE E SUITE 220 Seattle, WA 98102 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-26 |
| Decision Date | 2014-04-18 |
| Summary: | summary |