FDA device listing

CT210 Contact Tonometer

FDA device listing 1297178589 · REICHERT INC.

Key facts

Proprietary names CT210 Contact Tonometer
Owner/operator REICHERT INC.
Owner/operator number 9055850
Premarket submissions K000288
Product codes HKY
Device names HKY - Tonometer, Manual
Device class Class II
Classification regulations (21 CFR) 886.1930
Review panels Ophthalmic
Registered establishments REICHERT INC.
Establishment registrations 1319721
FEI numbers 1000159913
Establishment operations Manufacturer
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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