K122111 is an FDA 510(k) clearance for the RESPIRONICS SIMPLYCLEAR DEVICE. This device is classified as a Intra-pulmonary Percussive Vibration (ipv) Devices (Class II - Special Controls, product code SDT).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on December 31, 2012, 167 days after receiving the submission on July 17, 2012.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5665. It Is Intended To Mobilize Mucus Using Vibration And/or Pressure Delivered Through A Mouthpiece Into The Airways..
| 510(k) Number | K122111 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2012 |
| Decision Date | December 31, 2012 |
| Days to Decision | 167 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | SDT — Intra-pulmonary Percussive Vibration (ipv) Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5665 |
| Definition | It Is Intended To Mobilize Mucus Using Vibration And/or Pressure Delivered Through A Mouthpiece Into The Airways. |