510(k) K090671

PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D by Contec Medical System Co., Ltd. — Product Code DQA

K090671 is an FDA 510(k) premarket notification submitted by Contec Medical System Co., Ltd. for the device "PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D". The FDA issued a decision of Substantially Equivalent on June 11, 2009. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Contec Medical System Co., Ltd. has at least 10 other 510(k) clearances on record.