O2 Concepts Oxlife Independence Model 301-0001

Generator, Oxygen, Portable

O2 Concepts LLC

The following data is part of a premarket notification filed by O2 Concepts Llc with the FDA for O2 Concepts Oxlife Independence Model 301-0001.

Pre-market Notification Details

Device IDK182454
510k NumberK182454
Device Name:O2 Concepts Oxlife Independence Model 301-0001
ClassificationGenerator, Oxygen, Portable
Applicant O2 Concepts LLC 199 Park Road Extension Middlebury,  CT  06762
ContactKathryn G. Forgione
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2018-09-07
Decision Date2018-12-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00869694000105 K182454 000
00869694000129 K182454 000
00869694000136 K182454 000
00869694000143 K182454 000

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