FDA 510(k) K982408, AEROTEE, MODEL # 1001, by Piper Medical Products
FDA 510(k) K982408, AEROTEE, MODEL # 1001, by Piper Medical Products
| 510(k) Number | K982408 |
| Device Classification Name | Nebulizer (Direct Patient Interface) |
| Device Name | AEROTEE, MODEL # 1001 |
| Applicant | Piper Medical Products 3929 Arderly Ct. Sacramento, CA 95826 |
| Regulation Number | 868.563 |
| Classification Product Code | CAF |
| Date Received | 07/10/1998 |
| Decision Date | 09/14/1998 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Anesthesiology |
| 510k Review Panel | Anesthesiology |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 143 |
| Redacted Pages | 37 |
| Unredacted Pages | 106 |
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