510(k) K871302

MODEL 2000W OPTION H CONFIGURATION by Edentec Corp. — Product Code BZQ

K871302 is an FDA 510(k) premarket notification submitted by Edentec Corp. for the device "MODEL 2000W OPTION H CONFIGURATION". The FDA issued a decision of Substantially Equivalent on April 20, 1987. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Edentec Corp. has at least 10 other 510(k) clearances on record.