510(k) K081712

FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 by Guangdong Biolight Meditech Co., Ltd. — Product Code DQA

K081712 is an FDA 510(k) premarket notification submitted by Guangdong Biolight Meditech Co., Ltd. for the device "FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700". The FDA issued a decision of Substantially Equivalent on Sep 12, 2008. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Guangdong Biolight Meditech Co., Ltd. has 20 other 510(k) clearances on record.