FDA device listing
989803171811 ECG 3 lead Grabber, AAMI + SpO2, Tele (ECG Lead Set + SpO2 Adapter),989803171821 ECG 5 lead Snaps, AAMI…
FDA device listing 1549806698 · NICOLAY GMBH
Key facts
| Proprietary names | 989803171811 ECG 3 lead Grabber, AAMI + SpO2, Tele (ECG Lead Set + SpO2 Adapter),989803171821 ECG 5 lead Snaps, AAMI, Tele (ECG Lead Set),989803171831 ECG 5 lead Grabber, AAMI, Tele (ECG Lead Set),989803171841 ECG 5 lead Snaps, AAMI + SpO2, Tele (ECG Lead Set + SpO2 Adapter),989803171851 ECG 5 lead Grabber, AAMI + SpO2, Tele (ECG Lead Set + SpO2 Adapter),989803171861 ECG 6 lead Grabber, AAMI, Tele… |
|---|---|
| Owner/operator | NICOLAY GMBH |
| Owner/operator number | 9022544 |
| Product codes | MHX |
| Device names | MHX - Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1025 |
| Review panels | Cardiovascular |
| Registered establishments | Nicolay GMBH |
| Establishment registrations | 9681377 |
| FEI numbers | 1000300598 |
| Establishment operations | Contract 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