510(k) K082641

FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL by Contec Medical System Co., Ltd. — Product Code DQA

K082641 is an FDA 510(k) premarket notification submitted by Contec Medical System Co., Ltd. for the device "FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL". The FDA issued a decision of Substantially Equivalent on November 10, 2008. 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.