The following data is part of a premarket notification filed by Piper Medical Products with the FDA for Aerotee, Model # 1001.
| Device ID | K982408 |
| 510k Number | K982408 |
| Device Name: | AEROTEE, MODEL # 1001 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PIPER MEDICAL PRODUCTS 3929 ARDERLY COURT Sacramento, CA 95826 |
| Contact | S. David Piper |
| Correspondent | S. David Piper PIPER MEDICAL PRODUCTS 3929 ARDERLY COURT Sacramento, CA 95826 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-10 |
| Decision Date | 1998-09-14 |