510(k) Report

Devices descending from K973419

5 later devices reach DMR Plus Disposable Manual Resuscitator through their predicates, nearest generation first.

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