XYZ SYSTEM— 510(k) K983550

Substantially Equivalent

Bio-Monitoring International Corp.

FDA 510(k) clearance K983550 for XYZ SYSTEM, Substantially Equivalent on 1999-01-07. Applicant: Bio-Monitoring International Corp.. Device class: 2.

Clearance details

Applicant: Bio-Monitoring International Corp.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1998-10-09
Decision date: 1999-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, 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.