The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for L4 Oxygen Concentrator.
| Device ID | K061261 |
| 510k Number | K061261 |
| Device Name: | L4 OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Zita A Yurko |
| Correspondent | Zita A Yurko RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-05 |
| Decision Date | 2006-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959022041 | K061261 | 000 |
| 00606959032620 | K061261 | 000 |
| 00606959032613 | K061261 | 000 |
| 00606959032606 | K061261 | 000 |
| 00606959032590 | K061261 | 000 |
| 00606959032583 | K061261 | 000 |
| 00606959032576 | K061261 | 000 |
| 00606959032569 | K061261 | 000 |
| 00606959032552 | K061261 | 000 |
| 00606959032545 | K061261 | 000 |
| 00606959032538 | K061261 | 000 |
| 00606959032521 | K061261 | 000 |
| 00606959032514 | K061261 | 000 |
| 00606959047921 | K061261 | 000 |
| 00606959032507 | K061261 | 000 |
| 00606959032491 | K061261 | 000 |
| 00606959032477 | K061261 | 000 |
| 00606959032637 | K061261 | 000 |
| 00606959032644 | K061261 | 000 |
| 00606959020436 | K061261 | 000 |
| 00606959014954 | K061261 | 000 |
| 00606959001077 | K061261 | 000 |
| 00606959032798 | K061261 | 000 |
| 00606959032781 | K061261 | 000 |
| 00606959032774 | K061261 | 000 |
| 00606959032767 | K061261 | 000 |
| 00606959032750 | K061261 | 000 |
| 00606959032736 | K061261 | 000 |
| 00606959032729 | K061261 | 000 |
| 00606959032705 | K061261 | 000 |
| 00606959032699 | K061261 | 000 |
| 00606959032682 | K061261 | 000 |
| 00606959032675 | K061261 | 000 |
| 00606959032668 | K061261 | 000 |
| 00606959032651 | K061261 | 000 |
| 00606959044241 | K061261 | 000 |