510(k) Report

Devices descending from K971243

12 later devices reach Ohmeda Infant Resuscitation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070247Giraffe and Panda Bag and Mask Resuscitation SystemOhmeda Medical20074Class I
+1K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical200710Class I
+2K140707Lifeborne Infant ResuscitatorInternational Biomedical20141—
+2K103317Resuscitation Unit 105Atom Medical Corporation20110—
+2K102542Resusci Flow; Resusci Flow 104Atom Medical Corporation20110—
+2K093913Mercury Medical T-Piece ResuscitatorMercury Medical, Inc.20101Class I
+2K070377Giraffe and Panda WarmerOhmeda Medical20073Class I
+3K182956Puffin Lite Infant Resuscitation SystemInternational Biomedical20190—
+3K173373SafeT T-Piece ResuscitatorVentlab, LLC20180—
+3K123309Giraffe and Panda WarmersOhmeda Medical20130Class I
+3K090697Modification to: Giraffe and Panda WarmerOhmeda Medical20091Class I
+3K072157Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Ohmeda Medical200721