510(k) Report

Devices descending from K974868

5 later devices reach Sigma Plus Monoplace Hyperbaric Chamber through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990927Sigma 3400 Monoplace Hyperbaric ChamberPerry Baromedical Corp.19994—
+2K081506Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber SystemsHyperbaric America, LLC20080—
+2K072427Sigma Series Hyperbaric ChamberPerry Baromedical Corp.20080—
+2K021693Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc.20022—
+3K053498Hyperox 101Wjo, Inc.20060—