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 |