FDA device listing

Humidifier, Non-Direct Patient Interface (Home-Use)

FDA device listing 1865992720 · Perfect Steam Appliances Ltd.

Key facts

Owner/operator Perfect Steam Appliances Ltd.
Owner/operator number 10053749
Product codes KFZ
Device names KFZ - Humidifier, Non-Direct Patient Interface (Home-Use)
Device class Class I
Classification regulations (21 CFR) 868.5460
Review panels Anesthesiology
Registered establishments Dongguan DaMei Appliances Ltd.
Establishment registrations 3013579894
FEI numbers 3013579894
Establishment operations 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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