510(k) Report

Devices descending from K061859

3 later devices reach Inovel Health Care N95 Particulate Respirators & Surgical Masks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102173Moldex-Metric Health Care N95 Particulate Respirator and Surgical Mask, Model 1712Moldex/Metric, Inc.20100—
+1K063747Inovel Health Care N95 Particulate Respirators and Surgical Masks, Models MFRN95-S…Inovel, LLC20070—
+1K062663Moldex Health Care N95 Particulate Respirators and Surgical MasksMoldex/Metric, Inc.20060—