FDA device listing

Stimulator, Electrical, Evoked Response

FDA device listing 1067891166 · REMINGTON MEDICAL, INC.

Key facts

Owner/operator REMINGTON MEDICAL, INC.
Owner/operator number 9006473
Product codes GWF, HAW
Device names GWF - Stimulator, Electrical, Evoked Response, HAW - Neurological Stereotaxic Instrument
Device class Class II
Classification regulations (21 CFR) 882.1870, 882.4560
Review panels Neurology
Registered establishments Remington Medical, Inc., REMINGTON MEDICAL, INC.
Establishment registrations 1056553, 3007014520
FEI numbers 1000132370, 3007014520
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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