Mini Accelograph Neuromuscular Trans. Monitor

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K892396 ↗

FDA Product Code

BXN

Device Class

Class II

Regulation

21 CFR Part 868.2775

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Am 706 Electromyograph, Stim., Neuro., External

  Class II

  FDA 510(k) K881196 Active Cleared 16 Jun 1989

• Elpha 2000

  Class II

  FDA 510(k) K914231 Active Cleared 28 May 1992

• Tof-Guard Transmission Monitor

  Class II

  FDA 510(k) K925159 Active Cleared 1 Sep 1993

• Myotest Dbs Nerve Stimulator

  Class II

  FDA 510(k) K890746 Active Cleared 14 Jul 1989

• Accelograph Neuromuscular Transmission Monitor

  Class II

  FDA 510(k) K893485 Active Cleared 28 Jul 1989

• Myotest - Nerve Stimulator

  Class II

  FDA 510(k) K860186 Active Cleared 20 Mar 1986

See all devices from Biometer Intl. A/S →

• What is the Mini Accelograph Neuromuscular Transmission Monitor used for?

  It is used to monitor neuromuscular block by stimulating nerves and measuring muscle response, helping anesthesiologists assess the depth of muscle relaxation during surgery.

• How is the Mini Accelograph Neuromuscular Transmission Monitor powered and what type of device is it?

  It is a battery-powered nerve stimulator device, designed for portability and use in clinical settings where external power may not be readily available.

• What regulatory pathway was used for the Mini Accelograph Neuromuscular Transmission Monitor and when was it cleared?

  It received traditional 510(k) clearance from the FDA on October 3, 1989, under submission K892396, demonstrating substantial equivalence to a legally marketed device.

• In which medical specialty is the Mini Accelograph Neuromuscular Transmission Monitor intended to be used?

  It is indicated for use in anesthesiology, as specified by the advisory committee classification and device labeling for monitoring neuromuscular transmission during anesthesia.