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K Number
K003520

Validate with FDA (Live)

Device Name
NEXAN SYSTEM, MODEL NX-300
Manufacturer
NEXAN LTD
Date Cleared
2000-12-13

(28 days)

Product Code
MWJ
Regulation Number
870.2800
Type
Special
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K061993,K113054
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).