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K Number
K010761
Device Name
SPL-50 SPIROLYSER
Manufacturer
FIM MEDICAL
Date Cleared
2002-03-05

(357 days)

Product Code
BZG
Regulation Number
868.1840
Type
Traditional
Panel
Anesthesiology
Reference & Predicate Devices
N/A
Predicate For
K161676
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 868.1840 Diagnostic spirometer.

(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).