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K Number
K011429
Device Name
MODEL 100 ACTIVITY MONITOR
Manufacturer
TELECOM MEDICAL, INC.
Date Cleared
2001-07-13

(65 days)

Product Code
GYD,KQX,LBB
Regulation Number
882.1950
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.1950 Tremor transducer.

(a)
Identification. A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.(b)
Classification. Class II (performance standards).