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K Number
K960840
Device Name
C.E. VASCULAR MACHINE
Manufacturer
C.E. DIAGNOSIS, INC.
Date Cleared
1997-03-28

(393 days)

Product Code
JEH
Regulation Number
868.1760
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.1760 Volume plethysmograph.

(a)
Identification. A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes.(b)
Classification. Class II (performance standards).