510(k) Report

Devices descending from K130947

10 later devices reach Fingertip Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172616Pulse OximeterBeijing Safe Heart Technology, Ltd.20180—
+1K141105Pulse OximeterHunan Accurate Bio-Medical Technology Co., Ltd.20148—
+2K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+3K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+3K230415Cadwell GuardianCadwell Industries, Inc.20230—
+3K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+3K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+4K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+4K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+5K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302