FDA device listing
5197-801 ZOOM COUPLER, 17.5MM (9118B),5197-804 ZOOM COUPLER, 19.5MM (9118),LENS ADAPTOR 20MM (9703),LENS ADAPTOR - 45MM…
FDA device listing 1426264415 · HOYA Corporation PENTAX Division
Key facts
| Proprietary names | 5197-801 ZOOM COUPLER, 17.5MM (9118B),5197-804 ZOOM COUPLER, 19.5MM (9118),LENS ADAPTOR 20MM (9703),LENS ADAPTOR - 45MM (9117),LENS ADAPTOR FOR RIGID-35MM (9116),PENTAX Medical Rigid Laryngostroboscope (9104),PENTAX Medical Rigid Laryngostroboscope (9107),RIGID ENDOSCOPE 70 DEG. 10MM (9106),RIGID ENDOSCOPE 70 DEG. 6MM (9108) |
|---|---|
| Owner/operator | HOYA Corporation PENTAX Division |
| Owner/operator number | 8030235 |
| Premarket submissions | K921285 |
| Product codes | EQL |
| Device names | EQL - Laryngostroboscope |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.4750 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | PENTAX of America, Inc. |
| Establishment registrations | 2518897 |
| FEI numbers | 1000080301 |
| Establishment operations | Complaint File Establishment |
| 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