510(k) Report

Devices descending from K992215

14 later devices reach Multicompatible Envitec Finger Clip Sensor, Multicompatible Envitec Adult… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097—
+1K041522Flexi-Stat Disposable Adhesive SPO2 SensorsElekon Industries U.S.A., Inc.20042—
+1K041647Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible)…Elekon Industries U.S.A., Inc.20042—
+1K041644Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible)…Elekon Industries U.S.A., Inc.20040—
+2K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+2K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+2K061191Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors for Use…Measurement Specialties, Inc.20060—
+2K042705Disposable Non-Adhesive SPO2 SensorsElekon Industries U.S.A., Inc.20041—
+2K042704Reusable Finger Clip SPO2 SensorsElekon Industries U.S.A., Inc.20041—
+3K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+3K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+3K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+3K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+4K233827OxiWearOxiwear, Inc.20240—