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510(k) Data Aggregation
K Number
K001278Device Name
SENSAIRE DIAGNOSTIC SPIROMETERManufacturer
Date Cleared
2000-11-29
(222 days)
Product Code
Regulation Number
868.1840Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SENSAIRE DIAGNOSTIC SPIROMETER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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