INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02

Generator, Oxygen, Portable

INVACARE CORP.

The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Invacare Platinum, Models Irc 5lx And Irc 5lx02.

Pre-market Notification Details

Device IDK020386
510k NumberK020386
Device Name:INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02
ClassificationGenerator, Oxygen, Portable
Applicant INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria,  OH  44036 -2125
ContactEdward A Knoll
CorrespondentEdward A Knoll
INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria,  OH  44036 -2125
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-06
Decision Date2002-07-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841447100249 K020386 000
00841447100218 K020386 000
00841447100188 K020386 000
00841447100171 K020386 000
00841447100089 K020386 000
00841447100058 K020386 000
00841447100041 K020386 000
00841447100010 K020386 000

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