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Biosaca System

by Biosys AB (Publ)

510(k) K984580

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984580 Date12 Mar 1999ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OLV
Device Class
Class II
Regulation
21 CFR Part 882.1400
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BIOSACA SYSTEM is a Standard Polysomnograph With Electroencephalograph, as defined by its device type and nomenclature authority. It is a Class II medical device under FDA regulation, identified by product code OLV and regulation number 882.1400.

The device received FDA 510(k) clearance (K984580) on March 12, 1999, determined to be substantially equivalent to a predicate device. It was submitted by Biosys AB (Publ) and reviewed by the Neurology advisory committee. The clearance is based on traditional review pathways and includes multiple registration and FEI numbers associated with the device.

Other devices from Biosys AB (Publ)

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the BIOSACA SYSTEM used for?

    The BIOSACA SYSTEM is a standard polysomnograph with electroencephalograph designed for monitoring and recording neurological activity during sleep studies, as defined by its device type and nomenclature authority under FDA regulation number 882.1400.

  • How was the BIOSACA SYSTEM cleared for market release?

    The BIOSACA SYSTEM received FDA 510(k) clearance (K984580) on March 12, 1999, through a traditional review pathway, determined to be substantially equivalent to a predicate device after evaluation by the Neurology advisory committee.

  • Who manufactures the BIOSACA SYSTEM and where is it registered?

    The BIOSACA SYSTEM is manufactured by Biosys AB (Publ) and is registered with multiple FEI and registration numbers, including 3011120183, associated with their facility in Chester, NY, United States.