The following data is part of a premarket notification filed by Respironics Inc., Sleep & Home Respiratory Group with the FDA for Alice Pdx.
| Device ID | K090484 |
| 510k Number | K090484 |
| Device Name: | ALICE PDX |
| Classification | Ventilatory Effort Recorder |
| Applicant | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Zita A Yurko |
| Correspondent | Zita A Yurko RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-25 |
| Decision Date | 2009-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959020689 | K090484 | 000 |
| 00606959038820 | K090484 | 000 |
| 00606959038813 | K090484 | 000 |
| 00606959033801 | K090484 | 000 |
| 00606959033580 | K090484 | 000 |
| 00606959033573 | K090484 | 000 |
| 00606959033566 | K090484 | 000 |
| 00606959060418 | K090484 | 000 |
| 00606959060401 | K090484 | 000 |
| 00606959060395 | K090484 | 000 |
| 00606959038837 | K090484 | 000 |
| 00606959038974 | K090484 | 000 |
| 00606959038981 | K090484 | 000 |
| 00606959020559 | K090484 | 000 |
| 00606959020481 | K090484 | 000 |
| 00606959020450 | K090484 | 000 |
| 00606959009790 | K090484 | 000 |
| 00606959003835 | K090484 | 000 |
| 00606959049710 | K090484 | 000 |
| 00606959039032 | K090484 | 000 |
| 00606959039025 | K090484 | 000 |
| 00606959039018 | K090484 | 000 |
| 00606959060388 | K090484 | 000 |