510(k) K103700

ESSENTIAL MRI PATIENT MONITOR by Invivo Corporation — Product Code DQA

K103700 is an FDA 510(k) premarket notification submitted by Invivo Corporation for the device "ESSENTIAL MRI PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on March 15, 2011. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Invivo Corporation has at least 10 other 510(k) clearances on record.