FDA device listing
Modular patient monitor. LMPLUS-12, LMPLUS-15, LMPLUS-17
FDA device listing 1595550195 · CAF Medical Solutions Inc
Key facts
| Proprietary names | Modular patient monitor. LMPLUS-12, LMPLUS-15, LMPLUS-17 |
|---|---|
| Owner/operator | CAF Medical Solutions Inc |
| Owner/operator number | 10084159 |
| Premarket submissions | K221616 |
| Product codes | BZK, BZQ, CBQ, CBR, CBS, CCK, CCL, DPS, DQA, DRG, DRT, DSB and 9 more |
| Device names | BZK - Spirometer, Monitoring (W/Wo Alarm), 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, DRG - Transmitters And Receivers, Physiological Signal, Radiofrequency, DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), DSB - Plethysmograph, Impedance and 9 more |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.1400, 868.1500, 868.1620, 868.1700, 868.1720, 868.1850, 868.2375, 870.1025, 870.1110, 870.1130, 870.2300, 870.2340 and 5 more |
| Review panels | Anesthesiology, Cardiovascular, General Hospital |
| Registered establishments | CAF MEDICAL SOLUTIONS INC |
| Establishment registrations | 3021559257 |
| FEI numbers | 3021559257 |
| Establishment operations | Manufacturer |
| 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