The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Venture Homefill Ii With Oxygen Conserver.
Device ID | K021685 |
510k Number | K021685 |
Device Name: | VENTURE HOMEFILL II WITH OXYGEN CONSERVER |
Classification | Generator, Oxygen, Portable |
Applicant | INVACARE CORP. ONE INVACARE WAY Elyria, OH 44036 -2125 |
Contact | Edward A Kroll |
Correspondent | Edward A Kroll INVACARE CORP. ONE INVACARE WAY Elyria, OH 44036 -2125 |
Product Code | CAW |
CFR Regulation Number | 868.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-22 |
Decision Date | 2002-07-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
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 |