The following data is part of a premarket notification filed by Respironics Inc. with the FDA for Simplygo Portable Oxygen Concentrator.
| Device ID | K111885 |
| 510k Number | K111885 |
| Device Name: | SIMPLYGO PORTABLE OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | RESPIRONICS INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Joseph E Olsavsky |
| Correspondent | Joseph E Olsavsky RESPIRONICS INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-01 |
| Decision Date | 2011-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959048867 | K111885 | 000 |
| 00606959028852 | K111885 | 000 |
| 00606959032446 | K111885 | 000 |
| 00606959032453 | K111885 | 000 |
| 00606959032460 | K111885 | 000 |
| 00606959035829 | K111885 | 000 |
| 00606959035836 | K111885 | 000 |
| 00606959035935 | K111885 | 000 |
| 00606959042094 | K111885 | 000 |
| 00606959047433 | K111885 | 000 |
| 00606959047440 | K111885 | 000 |
| 00606959047457 | K111885 | 000 |
| 00606959048317 | K111885 | 000 |
| 00606959048812 | K111885 | 000 |
| 00606959048836 | K111885 | 000 |
| 00606959048843 | K111885 | 000 |
| 00606959048850 | K111885 | 000 |
| 00606959053229 | K111885 | 000 |