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K Number
K955432
Device Name
CPX, CCM, CATH WITH 15% CO2
Manufacturer
MEDICAL GRAPHICS CORP.
Date Cleared
1996-07-01

(216 days)

Product Code
BZM
Regulation Number
868.1900
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.1900 Diagnostic pulmonary-function interpretation calculator.

(a)
Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.(b)
Classification. Class II (performance standards).