510(k) Report

Devices descending from K002036

10 later devices reach Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031465Model 2100 Pulse OximeterDolphin Medical, Inc.20030—
+1K024235Dolphin Medical Stand-Alone Pulse OximeterDolphin Medical, Inc.20034—
+1K014218Osi Medical Digital Dolphin 3000 Pulse Oximeter; Digital Dolphin Reusable Optical…Dolphin Medical, Inc.20020—
+1K021959Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100Dolphin Medical, Inc.20025—
+1K020075Modification to Osi Medical Dolphin Stand-Alone Pulse OximeterDolphin Medical, Inc.20026—
+1K012626Osi Medical Dolphin Stand-Alone Pulse Oximeter & Digital Dolphin Disposable Optical SendorOsi Medical, Inc.20017—
+1K012533Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and AccessoriesOsi Medical, Inc.20017—
+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—