The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Modification To Venture Iho 100 Complete Home Oxygen System.
| Device ID | K983777 |
| 510k Number | K983777 |
| Device Name: | MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM |
| Classification | Generator, Oxygen, Portable |
| Applicant | INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44036 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44036 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-26 |
| Decision Date | 1998-12-18 |