510(k) K896886

ARTEC RESPOND PULMONARY RESUSCITATOR by Artec Environmental Monitoring Division — Product Code BTM

K896886 is an FDA 510(k) premarket notification submitted by Artec Environmental Monitoring Division for the device "ARTEC RESPOND PULMONARY RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on February 6, 1990. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Artec Environmental Monitoring Division has at least 6 other 510(k) clearances on record.