510(k) K912234

SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION by Somnitec, Inc. — Product Code BZG

K912234 is an FDA 510(k) premarket notification submitted by Somnitec, Inc. for the device "SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION". The FDA issued a decision of Substantially Equivalent on July 22, 1991. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Somnitec, Inc. has at least 3 other 510(k) clearances on record.