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 a medical device manufactured by Ningbo David Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2019-11-25 under approval 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. It is manufactured by Ningbo David Medical Device Co., Ltd.. The 510(k) number is K190494.

When was Infant Incubator approved by the FDA?

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

What company makes Infant Incubator?

Infant Incubator is manufactured by Ningbo David Medical Device Co., Ltd..

What is the FDA product code for Infant Incubator?

The FDA product code for Infant Incubator is FMZ.

Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026)

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Official Source

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