The following data is part of a premarket notification filed by American Biosystems, Inc. with the FDA for Abi Vest Airway Clearance System.
| Device ID | K993629 |
| 510k Number | K993629 |
| Device Name: | ABI VEST AIRWAY CLEARANCE SYSTEM |
| Classification | Percussor, Powered-electric |
| Applicant | AMERICAN BIOSYSTEMS, INC. 20 YORKTON CT. St. Paul, MN 55117 |
| Contact | Eric J Larson |
| Correspondent | Eric J Larson AMERICAN BIOSYSTEMS, INC. 20 YORKTON CT. St. Paul, MN 55117 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-27 |
| Decision Date | 2000-01-21 |
| Summary: | summary |