510(k) Report

Devices descending from K862830

11 later devices reach Models 2R and 3R Pneupac Ventilator/Resuscitator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K024344Pneuton VentilatorAiron Corporation200310—
+2K080692Macs Cpap SystemAiron Corporation20087—
+2K043085Modification to: Pneuton VentilatorAiron Corporation20049—
+3K121379Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit AccessoryAiron Corporation20120—
+3K093862Carevent Handheld Cpap SystemO-Two Medical Technologies, Inc.20101—
+3K092085Ispira Resuscitation UnitNeoforce Group, Inc.20094—
+4K142096T-Piece ResuscitatorMercury Medical20140—
+4K112546O_Two Cpap SystemO-Two Medical Technologies, Inc.20110—
+4K110119Pressure ManometerNeoforce Group, Inc.20111—
+4K102649Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc.20112—
+5K122627Gio Digital Pressure GuagesGalemed Corp.20130—