FDA device listing

Lightning X Digital Thermometer

FDA device listing 1656288793 · Lightning X Products, Inc

Key facts

Proprietary names Lightning X Digital Thermometer
Owner/operator Lightning X Products, Inc
Owner/operator number 10051897
Premarket submissions K202009
Product codes FLL
Device names FLL - Continuous Measurement Thermometer
Device class Class II
Classification regulations (21 CFR) 880.2910
Review panels General Hospital
Registered establishments LIGHTNING X PRODUCTS, INC
Establishment registrations 3012311599
FEI numbers 3012311599
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 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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