510(k) Report

Devices descending from K020075

6 later devices reach Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031465Model 2100 Pulse OximeterDolphin Medical, Inc.20030—
+1K030629Dolphin Medical 2150 Handheld Pulse OximeterDolphin Medical, Inc.20032—
+1K024235Dolphin Medical Stand-Alone Pulse OximeterDolphin Medical, Inc.20034—
+1K021959Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100Dolphin Medical, Inc.20025—
+2K040380Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420Dolphin Medical, Inc.20041—
+3K242290DormoTech NLabDormotech Medical, Ltd.20250—