The following data is part of a premarket notification filed by American Biosystems, Inc. with the FDA for Thairapy(tm) Bronchial Drainage System, Model 101.
| Device ID | K884098 |
| 510k Number | K884098 |
| Device Name: | THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101 |
| Classification | Percussor, Powered-electric |
| Applicant | AMERICAN BIOSYSTEMS, INC. P.O. BOX 112 Marine On St. Croix, MN 55047 |
| Contact | Judith M Shade |
| Correspondent | Judith M Shade AMERICAN BIOSYSTEMS, INC. P.O. BOX 112 Marine On St. Croix, MN 55047 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-28 |
| Decision Date | 1988-12-16 |