Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Infant Incubator

K-Number: K190494 · 2019-11-25

ApplicantNingbo David Medical Device Co., Ltd.
Decision Date2019-11-25
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infant Incubator is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo David Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2019-11-25 under 510(k) number K190494. The device is classified under product code FMZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Infant Incubator?

Infant Incubator is a medical device that received FDA 510(k) clearance on 2019-11-25. The listed applicant is Ningbo David Medical Device Co., Ltd.. The 510(k) number is K190494.

When did Infant Incubator receive FDA 510(k) clearance?

Infant Incubator received FDA 510(k) clearance on 2019-11-25, under 510(k) number K190494.

Who is the listed applicant for Infant Incubator?

The FDA 510(k) record lists Ningbo David Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infant Incubator?

The FDA product code for Infant Incubator is FMZ.

Related Devices (Code: FMZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc.K251619Babyleo TN500Drägerwerk AG & Co. KGaAK251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc.K243437mOm Essential Incubator (ME1)Mom Incubators LimitedK213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.K182859Babyleo TN500Dragerwerk AG & CO Kgaa

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑