The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Invacare Check O2 Plus Concentrator Analyzer (check O2 Plus).
| Device ID | K984295 |
| 510k Number | K984295 |
| Device Name: | INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS) |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| 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 | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-01 |
| Decision Date | 1999-07-09 |
| Summary: | summary |