FDA device listing
DRE Waveline SV10 Patient Monitor,DRE Waveline SV12 Patient Monitor,DRE Waveline SV15 Patient Monitor
FDA device listing 1239700981 · DRE Resume LLC
Key facts
| Proprietary names | DRE Waveline SV10 Patient Monitor,DRE Waveline SV12 Patient Monitor,DRE Waveline SV15 Patient Monitor |
|---|---|
| Owner/operator | DRE Resume LLC |
| Owner/operator number | 10092249 |
| Premarket submissions | K232962 |
| Product codes | BZQ, CBQ, CBR, CBS, CCK, CCL, DPS, DQA, DRT, DSI, DSK, DXN and 6 more |
| Device names | BZQ - Monitor, Breathing Frequency, CBQ - Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration), CBR - Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.), CBS - Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.), CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, CCL - Analyzer, Gas, Oxygen, Gaseous-Phase, DPS - Electrocardiograph, DQA - Oximeter, DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), DSI - Detector And Alarm, Arrhythmia, DSK - Computer, Blood-Pressure, DXN - System, Measurement, Blood-Pressure, Non-Invasive and 6 more |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.1400, 868.1500, 868.1620, 868.1700, 868.1720, 868.2375, 870.1025, 870.1110, 870.1130, 870.2300, 870.2340, 870.2700 and 1 more |
| Review panels | Anesthesiology, Cardiovascular, General Hospital |
| Registered establishments | DRE Med |
| Establishment registrations | 1000122786 |
| FEI numbers | 1000122786 |
| Establishment operations | Repackager/Relabeler |
| 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