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K Number
K101968
Device Name
SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
Manufacturer
ST. JUDE MEDICAL
Date Cleared
2010-09-15

(65 days)

Product Code
MXC
Regulation Number
870.2800
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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).