The following data is part of a premarket notification filed by Medel S.p.a. with the FDA for Ag-edge, Model 91200.
| Device ID | K063103 |
| 510k Number | K063103 |
| Device Name: | AG-EDGE, MODEL 91200 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MEDEL S.P.A. 112 CAVISTON WAY Cary, NC 27519 |
| Contact | Terrence O'brien |
| Correspondent | Terrence O'brien MEDEL S.P.A. 112 CAVISTON WAY Cary, NC 27519 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-10 |
| Decision Date | 2007-01-08 |