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510(k) Data Aggregation
K Number
K983550Device Name
XYZ SYSTEM
Manufacturer
Date Cleared
1999-01-07
(90 days)
Product Code
Regulation Number
882.5050Why did this record match?
Applicant Name (Manufacturer) :
BIO-MONITORING INTERNATIONAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The XYZ System is intended for biofeedback for relaxation and re-education of muscles.
Device Description
The XYZ System contains 5 major parts. The Analog to Digital Housing with Isolation Ampitifiers and Isolated Power, the Analog to Digital Housing with Issac De Amplifiers an Housing with Isolathon Ampilliers and Toulater Converter, the IBM-PC compatible computer and XYZ Software.
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