LogoFDA 510(k) Search
K Number
K010396
Device Name
C. NET 2100
Manufacturer
CARDIONETICS, LTD.
Date Cleared
2001-10-04

(237 days)

Product Code
MLO
Regulation Number
870.2800
Type
Traditional
Panel
CV
Reference & Predicate Devices
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).