The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Simple T Pediatric Nasal Mask.
| Device ID | K151120 |
| 510k Number | K151120 |
| Device Name: | Simple T Pediatric Nasal Mask |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LANE Murrysville, PA 15668 |
| Contact | Shaylee Masilunas |
| Correspondent | Shaylee Masilunas RESPIRONICS, INC. 1001 MURRY RIDGE LANE Murrysville, PA 15668 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-27 |
| Decision Date | 2016-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959041417 | K151120 | 000 |
| 30606959041463 | K151120 | 000 |
| 30606959041470 | K151120 | 000 |
| 30606959041487 | K151120 | 000 |
| 30606959041494 | K151120 | 000 |
| 30606959041500 | K151120 | 000 |
| 30606959041517 | K151120 | 000 |
| 00606959041547 | K151120 | 000 |
| 00606959041554 | K151120 | 000 |
| 00606959041455 | K151120 | 000 |
| 00606959041431 | K151120 | 000 |
| 00606959041424 | K151120 | 000 |
| 00606959041448 | K151120 | 000 |
| 00606959026728 | K151120 | 000 |
| 00606959026742 | K151120 | 000 |
| 00606959057494 | K151120 | 000 |
| 00606959024236 | K151120 | 000 |
| 00606959026735 | K151120 | 000 |
| 00606959026766 | K151120 | 000 |
| 00606959041400 | K151120 | 000 |
| 00606959041561 | K151120 | 000 |
| 00606959041578 | K151120 | 000 |
| 00606959041691 | K151120 | 000 |
| 00606959041707 | K151120 | 000 |
| 00606959041714 | K151120 | 000 |
| 30606959041722 | K151120 | 000 |
| 30606959041739 | K151120 | 000 |
| 30606959041746 | K151120 | 000 |
| 30606959041753 | K151120 | 000 |
| 30606959041760 | K151120 | 000 |
| 00606959041684 | K151120 | 000 |
| 00606959041677 | K151120 | 000 |
| 00606959041660 | K151120 | 000 |
| 00606959041585 | K151120 | 000 |
| 00606959041592 | K151120 | 000 |
| 30606959041609 | K151120 | 000 |
| 30606959041616 | K151120 | 000 |
| 30606959041623 | K151120 | 000 |
| 30606959041630 | K151120 | 000 |
| 30606959041647 | K151120 | 000 |
| 30606959041654 | K151120 | 000 |
| 30606959041777 | K151120 | 000 |