The following data is part of a premarket notification filed by Smiths Medical with the FDA for Acapella Choice Blue Vibratory Pep Device.
| Device ID | K181660 |
| 510k Number | K181660 |
| Device Name: | Acapella Choice Blue Vibratory PEP Device |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | Smiths Medical 6000 Nathan Lane North Minneapolis, MN 55442 |
| Contact | Donna Semlak |
| Correspondent | Dawn Norman MRC-X, LLC 6075 Poplar Avenue, Suite 500 Memphis, TN 38119 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-25 |
| Decision Date | 2019-10-24 |
| Summary: | summary |