510(k) Report

Devices descending from K001242

18 later devices reach Isolette Infant Incubator, Model C2HS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172154Isolette 8000 plusDraeger Medical Sytems, Inc.20182—
+1K071977Tarry Medical Temperature ProbesTarry Medical Products, Inc.20080—
+1K070291Medix Natal Care Intensive Care Incubator, Models-Natal Care ST-MX/LX/BXMedix I.C.S.A.200702
+1K061280V-2200 Infant IncubatorNeoforce Group, Inc.20060—
+1K020543Ohmeda Medical Giraffe OmnibedOhmeda Medical20026Class I
+1K020547Ohmeda Medical Giraffe IncubatorOhmeda Medical200254
+1K020219Rpi Skin or Air Temperature ProbeReplacement Parts Industries, Inc.20021—
+2K243437mOm Essential Incubator (ME1)Mom Incubators Limited20250—
+2K182977Isolette 8000 PlusDraeger Medical Systems, Inc.20180—
+2K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company20163Class I
+2K152809Giraffe Incubator Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda, Inc.20153Class I
+2K072512Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda Uninterruptible…Datex-Ohmeda, Inc.20074—
+2K071175Ohmeda Medical Giraffe OmnibedGE Healthcare20075—
+3K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc.20222Class I
+3K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.20222Class I
+3K102226Dual Incu IAtom Medical Corporation201105
+4K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc.20251—
+5K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc.20260—