FDA device listing
1093, HEADSET HS3,Specula, 3mm, cerumen, 12,Specula, 3mm, normal, 12,Type 1076 - OTOcam 300,Type 1093 - Otoscan
FDA device listing 1687671386 · Natus Medical Incorporated
Key facts
| Proprietary names | 1093, HEADSET HS3,Specula, 3mm, cerumen, 12,Specula, 3mm, normal, 12,Type 1076 - OTOcam 300,Type 1093 - Otoscan |
|---|---|
| Owner/operator | Natus Medical Incorporated |
| Owner/operator number | 9004873 |
| Product codes | ERA |
| Device names | ERA - Otoscope |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.4770 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | Natus Manufacturing Limited |
| Establishment registrations | 3005581270 |
| FEI numbers | 3005581270 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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