FDA device listing

PMT STEREOTACTIC SYSTEMS,STEREOTACTIC SYSTEMS

FDA device listing 1036118425 · PMT CORP.

Key facts

Proprietary names PMT STEREOTACTIC SYSTEMS,STEREOTACTIC SYSTEMS
Owner/operator PMT CORP.
Owner/operator number 2182979
Premarket submissions K831329
Product codes HAW
Device names HAW - Neurological Stereotaxic Instrument
Device class Class II
Classification regulations (21 CFR) 882.4560
Review panels Neurology
Registered establishments PMT CORP.
Establishment registrations 2182979
FEI numbers 2182979
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 100–999 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

Browse all FDA device listings