COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE

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 Vascular Access; Compass Lumbar Puncture.

Pre-market Notification Details

Device IDK101518
510k NumberK101518
Device Name:COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE
ClassificationTransducer, Blood-pressure, Extravascular
Applicant MIRADOR BIOMEDICAL, INC. 2815 WASTLAKE AVENUE SUITE 300 Seattle,  WA  98102
ContactJustin Hulvershorn Md, Phd
CorrespondentJustin Hulvershorn Md, Phd
MIRADOR BIOMEDICAL, INC. 2815 WASTLAKE AVENUE SUITE 300 Seattle,  WA  98102
Product CodeDRS  
CFR Regulation Number870.2850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-02
Decision Date2010-10-13
Summary:summary

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