Biotrace-N, Ns, 410 and Rt

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

510(k) Number

K944496 ↗

FDA Product Code

DRX

FDA applicant

Msb , Ltd.

Device Class

Class II

Regulation

21 CFR Part 870.2360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Unilect, Monitab and Biotrace-Hr

  Class II

  FDA 510(k) K944497 Active Cleared 17 May 1996

• Neutralect Adult Standard, Return (Rem) & Paediatric Electrosurgery Plate (Modification)

  Class II

  FDA 510(k) K955261 Active Cleared 30 Jan 1996

• Msb Tens Electrodes (Disposable)

  Class II

  FDA 510(k) K980229 Active Cleared 27 Feb 1998

• Neutralect Adult Standard, Return (Rem), Paediatric Standard, Return (Rem)

  Class II

  FDA 510(k) K944817 Active Cleared 9 Nov 1994

• Ecotabs

  Class II

  FDA 510(k) K950587 Active Cleared 16 Oct 1995

• ECG Electrode

  Class II

  FDA 510(k) K944260 Active Cleared 7 Jul 1995

• What is the BIOTRACE-N, NS, 410 AND RT electrode used for?

  The BIOTRACE-N, NS, 410 AND RT electrode is designed for use with electrocardiograph (ECG) systems to monitor cardiac electrical activity, falling under the cardiovascular medical specialty as indicated by its product code DRX and regulatory classification.

• How was the BIOTRACE-N, NS, 410 AND RT electrode cleared for market?

  The device received FDA 510(k) clearance under number K944496 on May 16, 1996, following a traditional review process, and was determined to be substantially equivalent to a legally marketed predicate device, which is the basis for its Class II classification with special controls.

• Who manufactures the BIOTRACE-N, NS, 410 AND RT electrode and where are they located?

  The BIOTRACE-N, NS, 410 AND RT electrode is manufactured by Msb, Ltd., located at Hilldrop Ln., Ramsbury, Marlborough, Wiltshire, SN8 2RB, United Kingdom, as specified in the device’s authorization and submission details.