COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST

Transducer, Blood-pressure, Extravascular

MIRADOR BIOMEDICAL, INC.

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.

Pre-market Notification Details

Device IDK112203
510k NumberK112203
Device Name:COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST
ClassificationTransducer, Blood-pressure, Extravascular
Applicant MIRADOR BIOMEDICAL, INC. 2815 WASTLAKE AVENUE SUITE 220 Seattle,  WA  98102
ContactJustin Hulvershorn
CorrespondentJustin Hulvershorn
MIRADOR BIOMEDICAL, INC. 2815 WASTLAKE AVENUE SUITE 220 Seattle,  WA  98102
Product CodeDRS  
CFR Regulation Number870.2850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-01
Decision Date2011-12-14
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.