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 |