510(k) K101022

PULMOTRACK 5050 WHOLTER, MODEL 5050 by Karmelsonix — Product Code DSH

K101022 is an FDA 510(k) premarket notification submitted by Karmelsonix for the device "PULMOTRACK 5050 WHOLTER, MODEL 5050". The FDA issued a decision of Substantially Equivalent on July 9, 2010. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Karmelsonix has at least 3 other 510(k) clearances on record.