The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Respironics Simplyclear Device.
| Device ID | K122111 |
| 510k Number | K122111 |
| Device Name: | RESPIRONICS SIMPLYCLEAR DEVICE |
| Classification | Percussor, Powered-electric |
| 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 | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-17 |
| Decision Date | 2012-12-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959058477 | K122111 | 000 |