510(k) K021033

STIMUPLEX-DIG-RC NERVE STIMULATOR by B.Braun Medical, Inc. — Product Code BXN

K021033 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "STIMUPLEX-DIG-RC NERVE STIMULATOR". The FDA issued a decision of Substantially Equivalent on March 21, 2003. The device falls under product code BXN (Stimulator, Nerve, Battery-Powered), a Class II device regulated under 21 CFR 868.2775. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.