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K Number
K003667

Validate with FDA (Live)

Device Name
REVEAL PLUS INSERTABLE LOOP RECORDER
Manufacturer
MEDTRONIC VASCULAR
Date Cleared
2001-02-14

(78 days)

Product Code
MXC
Regulation Number
870.2800
Type
Traditional
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K063035,K071655,K103762
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).