510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984580Substantially Equivalent

Biosaca System

Biosys AB (Publ), Chester NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984580 is the FDA 510(k) clearance record for BIOSACA SYSTEM, a class II device, cleared for Biosys AB (Publ) on under FDA product code OLV (Standard Polysomnograph With Electroencephalograph). FDA's definition for product code OLV reads: "Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review...". FDA records list 2 510(k) clearances for Biosys AB (Publ), from to . As of , FDA records show no recalls naming K984580.

Clearance record

Decision date
Received
(79 days to decision)
Product code
OLV Standard Polysomnograph With Electroencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Biosys AB (Publ) 485 Laroe Rd., Chester NY
510(k) summary
Summary
Third party review
No

Clearances, product code OLV

Trailing 12 months
2 clearances under product code OLV in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OLV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260