FDA device listing
Patient Monitor models iM8,iM8A,iM8B,Patient Monitor models PM-2000A,PM-2000A+,PM-2000A Pro,Patient Monitor model…
FDA device listing 1965033097 · EDAN INSTRUMENTS, INC.
Key facts
| Proprietary names | Patient Monitor models iM8,iM8A,iM8B,Patient Monitor models PM-2000A,PM-2000A+,PM-2000A Pro,Patient Monitor model Waveline EZx |
|---|---|
| Owner/operator | EDAN INSTRUMENTS, INC. |
| Owner/operator number | 9055347 |
| Premarket submissions | K113653 |
| Product codes | DQA, DRT, DSA, DSI, DSK, DXN, FLL, MHX |
| Device names | DQA - Oximeter, DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), DSA - Cable, Transducer And Electrode, Patient, (Including Connector), DSI - Detector And Alarm, Arrhythmia, DSK - Computer, Blood-Pressure, DXN - System, Measurement, Blood-Pressure, Non-Invasive, FLL - Continuous Measurement Thermometer, MHX - Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1025, 870.1110, 870.1130, 870.2300, 870.2700, 870.2900, 880.2910 |
| Review panels | Cardiovascular, General Hospital |
| Registered establishments | EDAN INSTRUMENTS, INC. |
| Establishment registrations | 3003971136 |
| FEI numbers | 3003971136 |
| Establishment operations | Manufacturer |
| 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