The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Millennium M10 Oxygen Concentrator, Model M10600; With Opi, Model M10605.
| Device ID | K043006 |
| 510k Number | K043006 |
| Device Name: | MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-01 |
| Decision Date | 2005-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959015685 | K043006 | 000 |
| 00606959015678 | K043006 | 000 |
| 00606959012776 | K043006 | 000 |
| 00606959033214 | K043006 | 000 |
| 00606959033207 | K043006 | 000 |
| 00606959033191 | K043006 | 000 |
| 00606959033184 | K043006 | 000 |