FDA device listing
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
FDA device listing 1236210229 · REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
Key facts
| Owner/operator | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
|---|---|
| Owner/operator number | 9044740 |
| Premarket submissions | K173768 |
| Product codes | CCK, DPS, DQA, DRG, DRT, DSB, DSK, DXN, FFL, ITX, IYO, MHX and 2 more |
| Device names | CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, DPS - Electrocardiograph, DQA - Oximeter, DRG - Transmitters And Receivers, Physiological Signal, Radiofrequency, DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), DSB - Plethysmograph, Impedance, DSK - Computer, Blood-Pressure, DXN - System, Measurement, Blood-Pressure, Non-Invasive, FFL - Dislodger, Stone, Basket, Ureteral, Metal, ITX - Transducer, Ultrasonic, Diagnostic, IYO - System, Imaging, Pulsed Echo, Ultrasonic, MHX - Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) and 2 more |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.1400, 868.2375, 870.1025, 870.1110, 870.1130, 870.2300, 870.2340, 870.2700, 870.2770, 870.2910, 876.4680, 892.1560 and 1 more |
| Review panels | Anesthesiology, Cardiovascular, Gastroenterology & Urology, Radiology |
| Registered establishments | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
| Establishment registrations | 3003832357 |
| FEI numbers | 3003832357 |
| Establishment operations | Complaint File Establishment, 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