The following data is part of a premarket notification filed by Mirador Biomedical, Inc. with the FDA for Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment Pressure, Epidural Assist, Arterial Assist.
| Device ID | K112203 |
| 510k Number | K112203 |
| Device Name: | COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | MIRADOR BIOMEDICAL, INC. 2815 WASTLAKE AVENUE SUITE 220 Seattle, WA 98102 |
| Contact | Justin Hulvershorn |
| Correspondent | Justin Hulvershorn MIRADOR BIOMEDICAL, INC. 2815 WASTLAKE AVENUE 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 | 2011-08-01 |
| Decision Date | 2011-12-14 |
| Summary: | summary |