Michigan Instruments’ CPR product line offerings are registered as “Class II” medical devices by the U.S. Food and Drug Administration (FDA) per the Code of Federal Regulations, (21 CFR820). Additionally, Michigan Instruments complies with FDA Quality System Regulation (QSR) requirements cited in (21 CFR820).

Michigan Instruments maintains a Quality Management System (QMS) compliant to ISO 13485:2016.

Download a .pdf version of the certificate here, if desired.

For more information on the certifying authority, click here.

Model BSM - Breath Simulation Module - Manual