Monitor, GSR (NB-401)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K760084 ↗

FDA Product Code

HCC

Device Class

Class II

Regulation

21 CFR Part 882.5050

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Narco Tlecare Miniature Pressure Dome

  Class II

  FDA 510(k) K810431 Active Cleared 11 Mar 1981

• Motility Measurement Sys Mms-100

  Class II

  FDA 510(k) K832869 Active Cleared 31 Oct 1983

• Ultrasonic Qfm System 1000

  Class II

  FDA 510(k) K811376 Active Cleared 13 Aug 1981

• Porta-Fib Lpd

  Class II

  FDA 510(k) K801544 Active Cleared 14 Jul 1980

• Narcotrace 40 - NT40

  Class I

  FDA 510(k) K833656 Active Cleared 9 May 1984

• Physioscope

  Not classified

  FDA 510(k) K760083 Active Cleared 20 Jul 1976

See all devices from Narco Bio-Systems →

• What is the NB-401 GSR Monitor used for?

  The NB-401 GSR Monitor is a biofeedback device specifically designed for monitoring galvanic skin response in neurological applications. It helps measure changes in skin conductivity related to emotional or physiological arousal.

• Is the NB-401 GSR Monitor single-use or reusable?

  The device data does not specify whether the NB-401 GSR Monitor is single-use or reusable. This information would need to be confirmed with the manufacturer Narco Bio-Systems directly.

• What is the regulatory status of the NB-401 GSR Monitor?

  The NB-401 GSR Monitor received FDA 510(k) clearance on July 26, 1976, and is classified as a Class II medical device under product code HCC and classification 882.5050. It is not MRI compatible.

• How is the NB-401 GSR Monitor supplied?

  The NB-401 GSR Monitor is supplied by Narco Bio-Systems. The device data does not provide specific details about packaging or included accessories, so this information would need to be obtained directly from the manufacturer.