FDA device listing

Continuous Measurement Thermometer

FDA device listing 1627221962 · Compass Health Brands (Corporate Office)

Key facts

Owner/operator Compass Health Brands (Corporate Office)
Owner/operator number 2182780
Premarket submissions K091040
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 COMPASS HEALTH BRANDS (CORPORATE OFFICE)
Establishment registrations 3012316249
FEI numbers 3012316249
Establishment operations Complaint File Establishment
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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