Regulatory
Regulatory
SpotLight
SpotLight is FDA cleared and CE marked device distributed by Arineta. No all options available in all markets. SpotLight complies with the performance standards of 21 CFR, sub-chapter J, the applicable IEC 60601-1 series, NEMA XR-25, XR-26, XR-28 and XR29.
SpotLight Duo
SpotLight Duo is an FDA cleared device distributed by Arineta. SpotLight Duo complies with the performance standards of 21 CFR, sub-chapter J, the applicable IEC 60601-1 series, NEMA XR-25, XR-26, XR-28 and XR29. SpotLight Duo is not available in all markets.
CardioGraphe
CardioGraphe is the previous generation device, FDA cleared and CE marked. CardioGraphe complies with the performance standards of 21 CFR, sub-chapter J, the applicable IEC 60601-1 series, NEMA XR-25, XR-26, XR-28 and XR29.
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