Response System TN-3000

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K781743 ↗

FDA Product Code

GWL

Device Class

Class II

Regulation

21 CFR Part 882.1835

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Tracor Model Ra 208 Compliance Audiom

  Class II

  FDA 510(k) K760859 Active Cleared 29 Oct 1976

• Tracor Ra 410 Audiometer

  Class II

  FDA 510(k) K780450 Active Cleared 30 Mar 1978

• Audiometer Calibrator Model Ra 310

  Class I

  FDA 510(k) K780474 Active Cleared 30 Mar 1978

• Tracor RA400 Audiometer

  Class II

  FDA 510(k) K822414 Active Cleared 30 Aug 1982

• Tracor RA500 Audiometer

  Class II

  FDA 510(k) K891373 Active Cleared 14 Jul 1989

• Tracor Model RA600 Microprocessor Audiometer

  Class II

  FDA 510(k) K853245 Active Cleared 16 Oct 1985

See all devices from Tracor Instruments, Inc. →

• What is the TN-3000 Response System used for?

  The TN-3000 Response System is a physiological signal amplifier designed specifically for neurology applications. It processes and amplifies electrical signals from the nervous system, enabling accurate monitoring and analysis of neural activity in clinical environments where precise signal detection is essential.

• Is the TN-3000 a single-use or reusable device?

  The TN-3000 is a reusable medical instrument. It is intended for professional use in neurology settings and follows standard clinical instrument protocols for storage and maintenance to ensure optimal performance and longevity.

• Does the TN-3000 require any special sterility measures?

  The regulatory data for the TN-3000 does not specify any special sterility requirements. However, it is a reusable device, so adherence to standard clinical instrument protocols for cleaning and maintenance is recommended to maintain its functionality and safety.

• Can the TN-3000 be used in an MRI environment?

  No, the TN-3000 is explicitly intended for use in non-MRI environments. Its design and specifications do not support compatibility with magnetic resonance imaging systems.

• What regulatory clearance does the TN-3000 hold?

  The TN-3000 Response System holds FDA 510(k) clearance under the classification of a Class II device. It was determined to be substantially equivalent to a predicate device and is regulated under the FDA’s 510(k) pathway with clearance number K781743.