510(k) K901060

EDENTEC MODEL 2000W SYSTEM 700 MONITOR by Edentec Corp. — Product Code DQA

K901060 is an FDA 510(k) premarket notification submitted by Edentec Corp. for the device "EDENTEC MODEL 2000W SYSTEM 700 MONITOR". The FDA issued a decision of Substantially Equivalent on May 15, 1990. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Edentec Corp. has at least 10 other 510(k) clearances on record.