FDA device listing
OtoSight Middle Ear Scope
FDA device listing 1084017702 · Gentex Corporation
Key facts
| Proprietary names | OtoSight Middle Ear Scope |
|---|---|
| Owner/operator | Gentex Corporation |
| Owner/operator number | 10087496 |
| Product codes | QJG |
| Device names | QJG - Device System, Imaging, Tympanic Membrane And Middle Ear |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1560 |
| Review panels | Radiology |
| Registered establishments | GENTEX CORPORATION |
| Establishment registrations | 1000261180 |
| FEI numbers | 1000261180 |
| 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