VENTURE HOMEFILL II WITH OXYGEN CONSERVER

Generator, Oxygen, Portable

INVACARE CORP.

The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Venture Homefill Ii With Oxygen Conserver.

Pre-market Notification Details

Device IDK021685
510k NumberK021685
Device Name:VENTURE HOMEFILL II WITH OXYGEN CONSERVER
ClassificationGenerator, Oxygen, Portable
Applicant INVACARE CORP. ONE INVACARE WAY Elyria,  OH  44036 -2125
ContactEdward A Kroll
CorrespondentEdward A Kroll
INVACARE CORP. ONE INVACARE WAY Elyria,  OH  44036 -2125
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-22
Decision Date2002-07-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841447100270 K021685 000
00850018761352 K021685 000
00850018761369 K021685 000
00850018761376 K021685 000
00841447100096 K021685 000
00841447100119 K021685 000
00841447100126 K021685 000
00841447100133 K021685 000
00841447100140 K021685 000
00841447100256 K021685 000
00850018761307 K021685 000

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