510(k) Report

Devices descending from K013137

5 later devices reach Algo 3 Newborn Hearing Screener through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111555Circumaural Adhesive ReplacementR & D Medical Products, Inc.20110—
+1K073665Algo 5 Newborn Hearing ScreenerNatus Medical, Inc.20081—
+1K030823Algo 3I Newborn Hearing ScreenerNatus Medical, Inc.200311
+2K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20240—
+2K211147ALGO 7iPath Medical GmbH20210—