The following data is part of a premarket notification filed by Advanced Respiratory with the FDA for Abi Vest Airway Clearance System.
| Device ID | K012928 |
| 510k Number | K012928 |
| Device Name: | ABI VEST AIRWAY CLEARANCE SYSTEM |
| Classification | Percussor, Powered-electric |
| Applicant | ADVANCED RESPIRATORY 1020 WEST COUNTY RD. F St. Paul, MN 55126 |
| Contact | Eric J Larson |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-08-31 |
| Decision Date | 2001-10-09 |
| Summary: | summary |