The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Mobilaire V Oxygen Concentrator.
| Device ID | K891488 |
| 510k Number | K891488 |
| Device Name: | MOBILAIRE V OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Contact | James R Thaler |
| Correspondent | James R Thaler INVACARE CORP. 899 CLEVELAND ST. 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 | 1989-03-17 |
| Decision Date | 1989-05-25 |