510(k) Report

Devices descending from K862198

12 later devices reach Sigma II - Dual Place Hyperbaric Chamber through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021690Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-M3+1Pan-America Hyperbarics, Inc.20020—
+1K981938Tampa Hyperbaric Monoplace ChamberTampa Hyperbaric Ent.19993—
+1K983648Sigma Plus/ II Multiplace Hyperbaric SystemPerry Baromedical Services19991—
+1K960389Hyperbaric ChamberTampa Hyperbaric Ent.19965—
+2K030418Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber SystemMakai Marine Industries, Inc.20040—
+2K021693Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc.20022—
+2K011866Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 SeriesHyperbaric Technologies, Inc.20023—
+3K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control…Oxyheal Medical Systems, Inc.20161—
+3K081506Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber SystemsHyperbaric America, LLC20080—
+3K053498Hyperox 101Wjo, Inc.20060—
+3K052866Oxyheal 1000 Monoplace Hyperbaric ChamberOxyheal Health Group20050—
+4K163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc.20170—