510(k) Report

Devices descending from K012533

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031465Model 2100 Pulse OximeterDolphin Medical, Inc.20030—
+1K024235Dolphin Medical Stand-Alone Pulse OximeterDolphin Medical, Inc.20034—
+1K021959Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100Dolphin Medical, Inc.20025—
+1K020075Modification to Osi Medical Dolphin Stand-Alone Pulse OximeterDolphin Medical, Inc.20026—
+2K030629Dolphin Medical 2150 Handheld Pulse OximeterDolphin Medical, Inc.20032—
+3K040380Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420Dolphin Medical, Inc.20041—
+4K242290DormoTech NLabDormotech Medical, Ltd.20250—