510(k) K101983

CRITICAL CARE ASSESSMENT by Critical Patient Care, Inc. — Product Code JOM

K101983 is an FDA 510(k) premarket notification submitted by Critical Patient Care, Inc. for the device "CRITICAL CARE ASSESSMENT". The FDA issued a decision of Substantially Equivalent on September 21, 2010. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780.