FDA device listing
Aerogen Go AC/DC Adapter,Aerogen Go Medication Reservoir,Aerogen Go Vibrating Mesh Nebulizer,Aerogen Go Vibrating Mesh…
FDA device listing 2069584158 · HCMed Innovations Co., Ltd.
Key facts
| Proprietary names | Aerogen Go AC/DC Adapter,Aerogen Go Medication Reservoir,Aerogen Go Vibrating Mesh Nebulizer,Aerogen Go Vibrating Mesh Nebulizer, Aerogen Go® Mask (Adult), Aerogen Go® Mask (Pediatric), Aerogen Go® Mouthpiece,Pulmogine® |
|---|---|
| Owner/operator | HCMed Innovations Co., Ltd. |
| Owner/operator number | 10082903 |
| Premarket submissions | K202171 |
| Product codes | CAF |
| Device names | CAF - Nebulizer (Direct Patient Interface) |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5630 |
| Review panels | Anesthesiology |
| Registered establishments | HCMED INNOVATIONS CO., LTD. |
| Establishment registrations | 3016750005 |
| FEI numbers | 3016750005 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database