FDA device listing

Electrode, Ph, Stomach

FDA device listing 1056982157 · DIVERSATEK HEALTHCARE INC

Key facts

Owner/operator DIVERSATEK HEALTHCARE INC
Owner/operator number 2183446
Product codes FFT
Device names FFT - Electrode, Ph, Stomach
Device class Class I
Classification regulations (21 CFR) 876.1400
Review panels Gastroenterology & Urology
Registered establishments Diversatek Vietnam Company Limited
Establishment registrations 3009106214
FEI numbers 3009106214
Establishment operations Contract Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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