510(k) Report

Devices descending from K050193

1 later device reach Gerson 2130/31 Type N95 Niosh Certified Surgical Respirator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063334Shanghai Ganghai Model Giko 1400Shanghai Gangkai Purifying Products Co., Ltd.20060—