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 |
| 00841447103349 | K021685 | 000 |
| 00841447103356 | K021685 | 000 |
| 00841447103363 | K021685 | 000 |
| 00850018761307 | 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 |
| 00841447103332 | K021685 | 000 |