FDA device listing
RD SET Neo
FDA device listing 1624560802 · MASIMO CORPORATION
Key facts
| Proprietary names | RD SET Neo |
|---|---|
| Owner/operator | MASIMO CORPORATION |
| Owner/operator number | 9031881 |
| Premarket submissions | K191059 |
| Product codes | BZQ, CCK, DQA, DXN, FLL, JKS, MWI |
| Device names | BZQ - Monitor, Breathing Frequency, CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, DQA - Oximeter, DXN - System, Measurement, Blood-Pressure, Non-Invasive, FLL - Continuous Measurement Thermometer, JKS - Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide, MWI - Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.3220, 868.1400, 868.2375, 870.1130, 870.2300, 870.2700, 880.2910 |
| Review panels | Anesthesiology, Cardiovascular, Clinical Toxicology, General Hospital |
| Registered establishments | Industrial Vallera de Mexicali, S. A. de C. V., Industrial Vallera de Mexicali, S.A. de C.V. (Terra), MASIMO CORPORATION, Masimo Medical Technologies (Malaysia) SDN BHD |
| Establishment registrations | 3004415095, 3011353843, 3016674095, 3027256461 |
| FEI numbers | 3004415095, 3011353843, 3016674095, 3027256461 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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