FDA device listing
CH-S190-08-LB,CH-S190-XZ-Q,CH-S700-XZ-EA,CLL-S700,CV-1500,MAJ-2363,MAJ-2432,MAJ-2511,MAJ-2512,OTV-S200,OTV-S700
FDA device listing 1510354520 · OLYMPUS CORPORATION
Key facts
| Proprietary names | CH-S190-08-LB,CH-S190-XZ-Q,CH-S700-XZ-EA,CLL-S700,CV-1500,MAJ-2363,MAJ-2432,MAJ-2511,MAJ-2512,OTV-S200,OTV-S700 |
|---|---|
| Owner/operator | OLYMPUS CORPORATION |
| Owner/operator number | 9067818 |
| Product codes | FET |
| Device names | FET - Endoscopic Video Imaging System/Component, Gastroenterology-Urology |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Gyrus ACMI, Inc., OLYMPUS MEDICAL SYSTEMS CORP., SHIRAKAWA OLYMPUS CO., LTD. |
| Establishment registrations | 8010047, 3002808148, 3011050570 |
| FEI numbers | 3002807795, 3002808148, 3011050570 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| 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