510(k) Report

Devices descending from K060739

3 later devices reach Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072757Dive and Shallow and Grand DiveSummit TO Sea20082—
+2K171899Revitalair 430FOxavita Srl20191—
+3K220290Revitalair 430+Us Hyperbaric Network20230—