FDA device listing

TPC Non-Contact Digital Thermometer

FDA device listing 2004963214 · TPC ADVANCED TECHNOLOGY, INC.

Key facts

Proprietary names TPC Non-Contact Digital Thermometer
Owner/operator TPC ADVANCED TECHNOLOGY, INC.
Owner/operator number 9034634
Premarket submissions K180207
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 TPC ADVANCED TECHNOLOGY, INC.
Establishment registrations 2031508
FEI numbers 3001708019
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 UDI devices (GUDID) under the same submission
  • 10–99 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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