The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Venture Home Fill Ii, Model Ioh 200.
| Device ID | K003939 |
| 510k Number | K003939 |
| Device Name: | VENTURE HOME FILL II, MODEL IOH 200 |
| 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 | 2000-12-21 |
| Decision Date | 2001-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841447100195 | K003939 | 000 |
| 00841447100164 | K003939 | 000 |
| 00841447100034 | K003939 | 000 |