The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Simple T Youth Nasal Mask.
| Device ID | K140268 |
| 510k Number | K140268 |
| Device Name: | SIMPLE T YOUTH NASAL MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Colleen Witt |
| Correspondent | Colleen Witt RESPIRONICS, INC. 1001 MURRY RIDGE LN. 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 | 2014-02-12 |
| Decision Date | 2014-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959040007 | K140268 | 000 |
| 00606959039995 | K140268 | 000 |
| 00606959039988 | K140268 | 000 |
| 00606959039971 | K140268 | 000 |