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.

Michigan Instruments, Inc. Downloads

MII Thumper - Model 1077CC - Mechanical CPR Device - Manual

Life-Stat - Model 1008MII - Mechanical CPR Devices - Manual

Model BSM - Breath Simulation Module - Manual

MI - Model SBL - Spontaneous Breathing Lung Simulator - Operations Manual

Training & Test Lung Training & Test Lung - Operation Manual

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