FDA device listing

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

FDA device listing 1303891664 · Ningbo Dechang Electrical Appliance Co.,Ltd

Key facts

Owner/operator Ningbo Dechang Electrical Appliance Co.,Ltd
Owner/operator number 10060951
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 NINGBO DECHANG ELECTRICAL APPLIANCE CO.,LTD
Establishment registrations 3015603280
FEI numbers 3015603280
Establishment operations Complaint File Establishment, 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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