510(k) K013137

ALGO 3 NEWBORN HEARING SCREENER by Natus Medical, Inc. — Product Code GWJ

K013137 is an FDA 510(k) premarket notification submitted by Natus Medical, Inc. for the device "ALGO 3 NEWBORN HEARING SCREENER". The FDA issued a decision of Substantially Equivalent on October 16, 2001. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Natus Medical, Inc. has at least 10 other 510(k) clearances on record.