Infant Incubator

FDA 510(k) K190494 · Ningbo David Medical Device Co., Ltd.

Substantially Equivalent

510(k) numberK190494

Submission

Device name
Infant Incubator
Applicant
Ningbo David Medical Device Co., Ltd.
Ningbo, CN
Received
February 28, 2019
Decision date
November 25, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FMZ – Incubator, Neonatal
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5400
Specialty
General Hospital

Other 510(k)s with product code FMZ

510(k)DeviceApplicantDecision
K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)FMZ · Traditional Datex-Ohmeda, Inc.07/28/2026SE
K251619Babyleo TN500FMZ · Traditional Drägerwerk AG & Co. KGaA02/13/2026SE
K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional Datex-Ohmeda, Inc.10/22/2025SE
K243437mOm Essential Incubator (ME1)FMZ · Traditional Mom Incubators Limited08/14/2025SE
K213553Giraffe Incubator Carestation CS1FMZ · Traditional Datex Ohmeda, Inc.03/02/2022SE
K182859Babyleo TN500FMZ · Special Dragerwerk AG & CO Kgaa02/22/2019SE
K182977Isolette 8000 PlusFMZ · Special Draeger Medical Systems, Inc.11/21/2018SE
K172154Isolette 8000 plusFMZ · Traditional Draeger Medical Sytems, Inc.04/19/2018SE
K162821Babyleo TN500FMZ · Traditional Draegerwerk AG & CO Kgaa06/23/2017SE
K152814Giraffe OmniBed Carestation CS1FMZ · Special Ohmeda Medical, A Division of Datex-Ohmeda,Inc.…03/17/2016SE

Questions and answers

When was Infant Incubator cleared by the FDA?

Infant Incubator (K190494) received a 510(k) decision of Substantially Equivalent on November 25, 2019, 270 days after the submission was received.

What is the product code of K190494?

The FDA product code is FMZ – Incubator, Neonatal, a Class II (moderate risk) device regulated under 21 CFR 880.5400.