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510(k) Data Aggregation
K Number
K970840Device Name
INTELLIFLOW RESPIRATORY ANALYZER
Manufacturer
Date Cleared
1997-11-26
(264 days)
Product Code
Regulation Number
868.1880Why did this record match?
Applicant Name (Manufacturer) :
SIMTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SIMTEC Intelliflow Respiratory Analyzer is intended to acquire and interpret pulmonary function data and for CO analysis.
Device Description
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