The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Coughassist T70 Device.
| Device ID | K121955 |
| 510k Number | K121955 |
| Device Name: | COUGHASSIST T70 DEVICE |
| Classification | Device, Positive Pressure Breathing, Intermittent |
| Applicant | RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Colleen Witt |
| Correspondent | Colleen Witt RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Product Code | NHJ |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-03 |
| Decision Date | 2012-12-14 |
| Summary: | summary |