FDA device listing
1096 Diagnostic Probe Gen 2 kit,1096 Probe Diagnostic,1096 probe, Quick Check,1096 Quick Check Probe Gen 2 kit,Contra…
FDA device listing 1487501581 · Natus Medical Denmark ApS
Key facts
| Proprietary names | 1096 Diagnostic Probe Gen 2 kit,1096 Probe Diagnostic,1096 probe, Quick Check,1096 Quick Check Probe Gen 2 kit,Contra TDH39,MADSEN Zodiac,MADSEN Zodiac PC Clinical,MADSEN Zodiac PC Diagnostic,MADSEN Zodiac PC Quick Check,MADSEN Zodiac SA Clinical W/O Printer,MADSEN Zodiac SA Clinical W/Printer,MADSEN Zodiac SA Diagnostic W/O Printer,Madsen Zodiac SA Diagnostic w/printer,MADSEN Zodiac SA Quick… |
|---|---|
| Owner/operator | Natus Medical Denmark ApS |
| Owner/operator number | 10093195 |
| Premarket submissions | K161707 |
| Product codes | ETY |
| Device names | ETY - Tester, Auditory Impedance |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.1090 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | Natus Medical Denmark ApS, Natus Sensory Ireland Ltd |
| Establishment registrations | 9612197, 3034880867 |
| FEI numbers | 3002807554, 3034880867 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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