COMMANDER 111, MODEL CD300-CD399

System, Measurement, Blood-pressure, Non-invasive

CARDIOCOM LLC

The following data is part of a premarket notification filed by Cardiocom Llc with the FDA for Commander 111, Model Cd300-cd399.

Pre-market Notification Details

Device IDK091821
510k NumberK091821
Device Name:COMMANDER 111, MODEL CD300-CD399
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant CARDIOCOM LLC 4050 OLSEN MEMORIAL HIGHWAY SUITE 350 Minneapolis,  MN  55422
ContactJulie Bulver
CorrespondentJulie Bulver
CARDIOCOM LLC 4050 OLSEN MEMORIAL HIGHWAY SUITE 350 Minneapolis,  MN  55422
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-18
Decision Date2009-08-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000001957 K091821 000
00763000286996 K091821 000
00763000286989 K091821 000
00763000286972 K091821 000

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