510(k) K905575

MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON by Edentec Corp. — Product Code BZQ

K905575 is an FDA 510(k) premarket notification submitted by Edentec Corp. for the device "MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON". The FDA issued a decision of Substantially Equivalent on June 20, 1991. 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.