Cleared Special

Babyleo TN500

K182859 · Dragerwerk AG & CO Kgaa · General Hospital

Feb 2019

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K182859 is an FDA 510(k) clearance for the Babyleo TN500, a Incubator, Neonatal (Class II — Special Controls, product code FMZ), submitted by Dragerwerk AG & CO Kgaa (L?beck, DE). The FDA issued a Cleared decision on February 22, 2019, 134 days after receiving the submission on October 11, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5400.

Submission Details

510(k) Number	K182859 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 11, 2018
Decision Date	February 22, 2019
Days to Decision	134 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF