The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Venture Idd Oxygen Conserving Device Idd 20ex And 50ex.
| Device ID | K002284 |
| 510k Number | K002284 |
| Device Name: | VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX |
| Classification | Conserver, Oxygen |
| 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 | NFB |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-26 |
| Decision Date | 2000-10-24 |