510(k) Report

Devices descending from K993921

10 later devices reach NDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161536EasyOne Air SpirometerNdd Medizintechnik AG20171—
+1K160116SpiroScoutGanshorn Medizin Electronic GmbH20160—
+1K123896CCS-200 SpirometerBenson Medical Instruments Co.20134—
+1K092813Astrasonic Spirometer, Model 29-8000Sdi Diagnostics, Inc.20101—
+2K230178EasyOne Sky SpirometerNdd Medizintechnik AG20230—
+2K150137SpiroThorCohero Health, LLC20150—
+2K130322SPM-300Bionet Co., Ltd.20133—
+3K220535Cardio10Bionet Co., Ltd.20222—
+4K231160Cardio Q50, Cardio Q70Bionet Co., Ltd.20230—
+4K231150Cardio P1Bionet Co., Ltd.20230—