510(k) Report

Devices descending from K061996

7 later devices reach Sandman Pocket through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093728BE Micro, TreaEb Neuro S.P.A.20104—
+1K082853Clinical Oxygen Dose Recorder (Codr), Model 300-CRInspired Technologies, Inc.20090—
+1K083874GalaxyRespironics Inc., Sleep & Home Respiratory Group20090—
+2K133355Cadwell Flex Eeg/PSGCadwell Industries, Inc.20143—
+3K180269Cadwell Apollo SystemCadwell Industries, Inc.20182—
+4K201819Cadwell Apollo SystemCadwell Industries, Inc.20201—
+5K221959Q21Neurofield, Inc.20230—