FDA device listing

Oximeter

FDA device listing 1896699608 · CURBELL MEDICAL PRODUCTS, INC.

Key facts

Owner/operator CURBELL MEDICAL PRODUCTS, INC.
Owner/operator number 9033808
Premarket submissions K103685
Product codes DQA
Device names DQA - Oximeter
Device class Class II
Classification regulations (21 CFR) 870.2700
Review panels Cardiovascular
Registered establishments CURBELL MEDICAL PRODUCTS, INC.
Establishment registrations 1320360
FEI numbers 3000210521
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
  • 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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