FDA device listing
Fukuda Denshi DynaScope 7000 Series Patient Monito
FDA device listing 1963102388 · Fukuda Denshi Co., Ltd.
Key facts
| Proprietary names | Fukuda Denshi DynaScope 7000 Series Patient Monito |
|---|---|
| Owner/operator | Fukuda Denshi Co., Ltd. |
| Owner/operator number | 9028352 |
| Premarket submissions | K083697 |
| Product codes | BZQ, CCK, DQA, DRT, DSK, DXN, FFL, MHX |
| Device names | BZQ - Monitor, Breathing Frequency, CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, DQA - Oximeter, DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), DSK - Computer, Blood-Pressure, DXN - System, Measurement, Blood-Pressure, Non-Invasive, FFL - Dislodger, Stone, Basket, Ureteral, Metal, MHX - Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.1400, 868.2375, 870.1025, 870.1110, 870.1130, 870.2300, 870.2700, 876.4680 |
| Review panels | Anesthesiology, Cardiovascular, Gastroenterology & Urology |
| Registered establishments | FUKUDA DENSHI CO., LTD., FUKUDA DENSHI USA, INC. |
| Establishment registrations | 3031158, 9611031, 3009607734 |
| FEI numbers | 3000215024, 3002807019, 3009607734 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| 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