510(k) Report

Devices descending from K963058

6 later devices reach Infant Warmer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121625Lullaby TM WarmerWipro GE Healthcare Private, Ltd.20121—
+1K070377Giraffe and Panda WarmerOhmeda Medical20073Class I
+2K173516NuBorne Infant WarmerInternational Biomedical20180—
+2K123309Giraffe and Panda WarmersOhmeda Medical20130Class I
+2K090697Modification to: Giraffe and Panda WarmerOhmeda Medical20091Class I
+2K072157Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Ohmeda Medical200721