FDA device listing
Oximeter
FDA device listing 1215857750 · Sanicure BV
Key facts
| Owner/operator | Sanicure BV |
|---|---|
| Owner/operator number | 10052769 |
| Premarket submissions | K112478 |
| Product codes | DQA, DRT, DXN, FLL, MWI |
| Device names | DQA - Oximeter, DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), DXN - System, Measurement, Blood-Pressure, Non-Invasive, FLL - Continuous Measurement Thermometer, MWI - Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1130, 870.2300, 870.2700, 880.2910 |
| Review panels | Cardiovascular, General Hospital |
| Registered establishments | SANICURE BV |
| Establishment registrations | 3012494290 |
| FEI numbers | 3012494290 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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