510(k) K062468

SPECTRUM M2 MONITOR by Spectrum Medical, Llp — Product Code DRY

K062468 is an FDA 510(k) premarket notification submitted by Spectrum Medical, Llp for the device "SPECTRUM M2 MONITOR". The FDA issued a decision of Substantially Equivalent on September 13, 2006. The device falls under product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4330. Spectrum Medical, Llp has at least 10 other 510(k) clearances on record.