FDA device listing
Automatic Leakage Tester (PLT-V10c)
FDA device listing 1813296621 · HOYA Corporation PENTAX Division
Key facts
| Proprietary names | Automatic Leakage Tester (PLT-V10c) |
|---|---|
| Owner/operator | HOYA Corporation PENTAX Division |
| Owner/operator number | 8030235 |
| Product codes | PCV |
| Device names | PCV - Endoscopic Leak Tester |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| 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
- 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