BIOSACA SYSTEM— 510(k) K984580

Substantially Equivalent

Biosys AB (Publ)

FDA 510(k) clearance K984580 for BIOSACA SYSTEM, Substantially Equivalent on 1999-03-12. Applicant: Biosys AB (Publ). Device class: 2.

Clearance details

Applicant: Biosys AB (Publ)
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1998-12-23
Decision date: 1999-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chester, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.