510(k) Report

Devices descending from K943617

7 later devices reach Disposable Manual Resuscitator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K960468DMR/CO2 Combo KtiNellcor Puritan Bennett, Inc.19966—
+2K973419DMR Plus Disposable Manual ResuscitatorNellcor Puritan Bennett, Inc.19985—
+3K021328Smart Bag MOO-Two Systems International, Inc.20031—
+3K023494Nellcor Indgo Manual ResuscitatorNellcor Puritan Bennett, Inc.20030—
+3K991955Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2…Engineered Medical Systems19990—
+3K991953Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2…Engineered Medical Systems19990—
+4K212905Sotair DeviceSafe Bvm Corporation20220—