Biopack

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

510(k) Number

K993685 ↗

FDA Product Code

ILY

Device Class

Class II

Regulation

21 CFR Part 890.5500

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Q.P. Preamplifier Sys

  Class II

  FDA 510(k) K841683 Active Cleared 7 Jun 1984

• EEG Analyzer

  Class I

  FDA 510(k) K925735 Active Cleared 3 Dec 1993

• Bio/Scan Biolog Cassette Recorder

  Class II

  FDA 510(k) K841684 Active Cleared 7 Jun 1984

• EEG Electrodes

  Class II

  FDA 510(k) K841685 Active Cleared 7 Jun 1984

• Spinal Pad

  Class II

  FDA 510(k) K993684 Active Cleared 19 Jul 2000

• Bio-Log 8+1 Ambulatory Physiologic Recorder

  Class II

  FDA 510(k) K864928 Active Cleared 31 Mar 1987

See all devices from Bioscan, Inc. →

• What is the Biopack device used for?

  The Biopack is categorized as a physical medicine device. It is classified under product code ILY, which relates to its specific regulatory categorization within the physical medicine field.

• Who is the manufacturer of the Biopack?

  The Biopack is manufactured by Bioscan, Inc., located in Corrales, New Mexico. The company submitted the device for review, resulting in its FDA 510(k) clearance.

• What is the regulatory status of the Biopack?

  The Biopack received FDA 510(k) clearance under K993685 on July 18, 2000. It was determined to be substantially equivalent to other devices through a traditional clearance process.