510(k) Report

Devices descending from K081173

4 later devices reach Endoscopic CO2 Regulation Unit Ucr through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111648Bracco Diagnostics, Inc. CO2MPACT Endodcopic InsufflatorBracco Diagnostic, Inc.201131
+2K201096CO2mbiLEDKarl Storz Endoscopy America, Inc.20200—
+2K190985BAROnova Insufflation System, BAROnova Accessory KitBaronova, Inc.20190—
+2K162332Nexcore GI InsufflatorNexcore Technology, LLC20160—