510(k) Report

Devices descending from K102971

3 later devices reach Freedomaire Iii Surgical Helmet System Model 10322STK through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132386Totalshield Surgical Helmet SystemZimmer, Inc.20132—
+2K222214ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)Thi Total Healthcare Innovation GmbH20230—
+2K142166Total Shield Surgical;Toga (Regular, Large,X-Large);Hood; Helmet Advanced Helmet W/Led…Zimmer, Inc.20140—