Cleared Traditional

Giraffe Incubator Carestation CS1

K213553 · Datex-Ohmeda, Inc. · General Hospital
Mar 2022
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K213553 is an FDA 510(k) clearance for the Giraffe Incubator Carestation CS1, a Incubator, Neonatal (Class II — Special Controls, product code FMZ), submitted by Datex-Ohmeda, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on March 2, 2022, 114 days after receiving the submission on November 8, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5400.

Submission Details

510(k) Number K213553 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2021
Decision Date March 02, 2022
Days to Decision 114 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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