The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Invacare Platinum, Models Irc 5lx And Irc 5lx02.
| Device ID | K020386 |
| 510k Number | K020386 |
| Device Name: | INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 |
| Classification | Generator, Oxygen, Portable |
| Applicant | INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44036 -2125 |
| Contact | Edward A Knoll |
| Correspondent | Edward A Knoll 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 | 2002-02-06 |
| Decision Date | 2002-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841447100249 | K020386 | 000 |
| 00841447103325 | K020386 | 000 |
| 00841447103370 | K020386 | 000 |
| 00841447103387 | K020386 | 000 |
| 00841447100010 | K020386 | 000 |
| 00841447100041 | K020386 | 000 |
| 00841447100058 | K020386 | 000 |
| 00841447100089 | K020386 | 000 |
| 00841447100171 | K020386 | 000 |
| 00841447100188 | K020386 | 000 |
| 00841447100218 | K020386 | 000 |
| 00841447103318 | K020386 | 000 |