FDA device listing

Monitor, Breathing Frequency

FDA device listing 1995500223 · Wuhan Strong Electronics

Key facts

Owner/operator Wuhan Strong Electronics
Owner/operator number 10033669
Product codes BZQ, DPS, DQA, DXN, FLL, MWI
Device names BZQ - Monitor, Breathing Frequency, DPS - Electrocardiograph, DQA - Oximeter, DXN - System, Measurement, Blood-Pressure, Non-Invasive, FLL - Continuous Measurement Thermometer, MWI - Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device class Class II
Classification regulations (21 CFR) 868.2375, 870.1130, 870.2300, 870.2340, 870.2700, 880.2910
Review panels Anesthesiology, Cardiovascular, General Hospital
Registered establishments WUHAN STRONG ELECTRONICS
Establishment registrations 3008164770
FEI numbers 3008164770
Establishment operations Contract Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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

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