510(k) K823227

IMPEDANCE METER ON-1 by Kells Medical, Inc. — Product Code ETY

K823227 is an FDA 510(k) premarket notification submitted by Kells Medical, Inc. for the device "IMPEDANCE METER ON-1". The FDA issued a decision of Substantially Equivalent on November 22, 1982. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090. Kells Medical, Inc. has at least 10 other 510(k) clearances on record.