510(k) K051257

ADULT CEREBRAL OXIMETER, MODEL 2040 by Cas Medical Systems, Inc. — Product Code DQA

K051257 is an FDA 510(k) premarket notification submitted by Cas Medical Systems, Inc. for the device "ADULT CEREBRAL OXIMETER, MODEL 2040". The FDA issued a decision of Substantially Equivalent on December 22, 2005. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Cas Medical Systems, Inc. has at least 10 other 510(k) clearances on record.