510(k) Report

Devices descending from K031649

5 later devices reach SL8/DL8/TL20 Hyperbaric Oxygen Treatment Facilities through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240569FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd.20240—
+1K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control…Oxyheal Medical Systems, Inc.20161—
+1K082455Rectangular Multiplace Hyperbaric ChamberGulf Coast Hyperbarics, Inc.20090—
+1K053498Hyperox 101Wjo, Inc.20060—
+2K163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc.20170—