FDA device listing
BLK Pocket LED Otoscope,Compacset Portable Dignostic Set, Lumiview w/Various Transformer Sets and Accessories,Digital…
FDA device listing 1732037167 · BAXTER HEALTHCARE CORPORATION
Key facts
| Proprietary names | BLK Pocket LED Otoscope,Compacset Portable Dignostic Set, Lumiview w/Various Transformer Sets and Accessories,Digital MacroView, MacroView, 3.5V Diagnostic, Pneumatic, Op77E-Rating, PocketScope, Pocket Jr.,Otoscope and Accessories,Pocket LED Otoscopes (multi-colors) and accessories,Reusable and Disposable Specula,Dispensers,Welch Allyn LED Otoscope,Welch Allyn LumiView Clear Single-Use Ear… |
|---|---|
| Owner/operator | BAXTER HEALTHCARE CORPORATION |
| Owner/operator number | 1417572 |
| Product codes | ERA |
| Device names | ERA - Otoscope |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.4770 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | BAXTER HEALTHCARE CORPORATION, WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V., WELCH ALLYN, INC. |
| Establishment registrations | 1316463, 1416980, 3006087789 |
| FEI numbers | 1316463, 1416980, 3006087789 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, 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