FDA device listing

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

FDA device listing 1501994909 · BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.

Key facts

Owner/operator BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
Owner/operator number 9106400
Premarket submissions K211754
Product codes MWI
Device names MWI - Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device class Class II
Classification regulations (21 CFR) 870.2300
Review panels Cardiovascular
Registered establishments BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD., Tianjin Choice Medical Device Co., Ltd.
Establishment registrations 3005569927, 3015142815
FEI numbers 3005569927, 3015142815
Establishment operations Contract Manufacturer, Foreign Exporter, Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None 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

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