Cleared Traditional

Infant Incubator

K190494 · Ningbo David Medical Device Co., Ltd. · General Hospital

Nov 2019

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K190494 is an FDA 510(k) clearance for the Infant Incubator, a Incubator, Neonatal (Class II — Special Controls, product code FMZ), submitted by Ningbo David Medical Device Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on November 25, 2019, 270 days after receiving the submission on February 28, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5400.

Submission Details

510(k) Number	K190494 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 2019
Decision Date	November 25, 2019
Days to Decision	270 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF