510(k) Report

Devices descending from K960468

6 later devices reach DMR/CO2 Combo Kti through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973419DMR Plus Disposable Manual ResuscitatorNellcor Puritan Bennett, Inc.19985—
+2K021328Smart Bag MOO-Two Systems International, Inc.20031—
+2K023494Nellcor Indgo Manual ResuscitatorNellcor Puritan Bennett, Inc.20030—
+2K991955Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2…Engineered Medical Systems19990—
+2K991953Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2…Engineered Medical Systems19990—
+3K212905Sotair DeviceSafe Bvm Corporation20220—