K121955 is an FDA 510(k) clearance for the COUGHASSIST T70 DEVICE. This device is classified as a Device, Positive Pressure Breathing, Intermittent (Class II - Special Controls, product code NHJ).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on December 14, 2012, 164 days after receiving the submission on July 3, 2012.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K121955 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2012 |
| Decision Date | December 14, 2012 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NHJ — Device, Positive Pressure Breathing, Intermittent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |