Cleared Traditional

Babyleo TN500

K162821 · Draegerwerk AG & CO Kgaa · General Hospital
Jun 2017
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K162821 is an FDA 510(k) clearance for the Babyleo TN500, a Incubator, Neonatal (Class II — Special Controls, product code FMZ), submitted by Draegerwerk AG & CO Kgaa (L?beck, DE). The FDA issued a Cleared decision on June 23, 2017, 259 days after receiving the submission on October 7, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5400.

Submission Details

510(k) Number K162821 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2016
Decision Date June 23, 2017
Days to Decision 259 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMZ — Incubator, Neonatal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5400

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