The following data is part of a premarket notification filed by Respironics Inc. with the FDA for Simple T Nasal Mask.
| Device ID | K120145 |
| 510k Number | K120145 |
| Device Name: | SIMPLE T NASAL MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPIRONICS INC. 1001 MURRY RIDGE LANE Murrysville, PA 15668 |
| Contact | Michelle Brinker |
| Correspondent | Michelle Brinker RESPIRONICS INC. 1001 MURRY RIDGE LANE Murrysville, PA 15668 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-18 |
| Decision Date | 2012-03-30 |