510(k) Report

Devices descending from K011312

4 later devices reach BLKS-303 MK Monoplace Hyperbaric System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060739Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307Khrunichev State Research & Production Space Centr20063—
+2K072757Dive and Shallow and Grand DiveSummit TO Sea20082—
+3K171899Revitalair 430FOxavita Srl20191—
+4K220290Revitalair 430+Us Hyperbaric Network20230—