LD-Oxi System

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

LD TECHNOLOGY LLC

The following data is part of a premarket notification filed by Ld Technology Llc with the FDA for Ld-oxi System.

Pre-market Notification Details

Device IDK160956
510k NumberK160956
Device Name:LD-Oxi System
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant LD TECHNOLOGY LLC 100N. Biscayne Blvd, Suite 500 Miami,  FL  33132
ContactAlbert Maarek
CorrespondentAlbert Maarek
LD TECHNOLOGY LLC 100N. Biscayne Blvd, Suite 500 Miami,  FL  33132
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-05
Decision Date2016-07-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B322D0011 K160956 000

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