The following data is part of a premarket notification filed by Invacare Corporation with the FDA for Invacare Platinum Mobile Oxygen Concentrator.
| Device ID | K160630 |
| 510k Number | K160630 |
| Device Name: | Invacare Platinum Mobile Oxygen Concentrator |
| Classification | Generator, Oxygen, Portable |
| Applicant | INVACARE CORPORATION ONE INVACARE WAY Elyria, OH 44035 |
| Contact | Elijah N. Wreh |
| Correspondent | Elijah N. Wreh INVACARE CORPORATION ONE INVACARE WAY Elyria, OH 44035 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-07 |
| Decision Date | 2016-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841447102939 | K160630 | 000 |
| 00841447103400 | K160630 | 000 |
| 00841447103417 | K160630 | 000 |
| 00841447100355 | K160630 | 000 |
| 00841447100362 | K160630 | 000 |
| 00841447100379 | K160630 | 000 |
| 00841447100973 | K160630 | 000 |
| 00841447101086 | K160630 | 000 |
| 00841447102915 | K160630 | 000 |
| 00841447103394 | K160630 | 000 |