510(k) K093298

PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 by Keeler Instruments, Inc. — Product Code HKX

K093298 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000". The FDA issued a decision of Substantially Equivalent on December 10, 2010. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.