Infant Incubator— 510(k) K190494

Name: FDA 510(k) clearance K190494
Creator: U.S. Food and Drug Administration
Published: 2019-11-25

Substantially Equivalent

Ningbo David Medical Device Co., Ltd.

FDA 510(k) clearance K190494 for Infant Incubator, Substantially Equivalent on 2019-11-25. Applicant: Ningbo David Medical Device Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ningbo David Medical Device Co., Ltd.
Product code: Code FMZ
Device class: Class 2
Regulation: 21 CFR 880.5400
Advisory panel: General Hospital
Date received: 2019-02-28
Decision date: 2019-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ningbo, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMZ

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K260326 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)2026-07-28
K251619 — Babyleo TN5002026-02-13
K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)2025-10-22
K243437 — mOm Essential Incubator (ME1)2025-08-14
K213553 — Giraffe Incubator Carestation CS12022-03-02

Adverse events under product code FMZ

product code FMZ

Death: 2
Malfunction: 457
Other: 1
Total: 460

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.