The following data is part of a premarket notification filed by Respiratory Technologies, Incorporated with the FDA for The Incourage System.
| Device ID | K051383 |
| 510k Number | K051383 |
| Device Name: | THE INCOURAGE SYSTEM |
| Classification | Percussor, Powered-electric |
| Applicant | RESPIRATORY TECHNOLOGIES, INCORPORATED 8095 215 STREET WEST Lakeville, MN 55044 |
| Contact | Mario Nozzarella |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-05-27 |
| Decision Date | 2005-06-17 |
| Summary: | summary |