The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Venture Iho 100 Home Fill Complete Home Oxygen System.
| Device ID | K983627 |
| 510k Number | K983627 |
| Device Name: | VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM |
| Classification | Generator, Oxygen, Portable |
| Applicant | INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44036 -2125 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 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 | 1998-10-15 |
| Decision Date | 1999-10-22 |