Cleared Special

Isolette 8000 Plus

K182977 · Draeger Medical Systems, Inc. · General Hospital
Nov 2018
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K182977 is an FDA 510(k) clearance for the Isolette 8000 Plus, a Incubator, Neonatal (Class II — Special Controls, product code FMZ), submitted by Draeger Medical Systems, Inc. (Telford, US). The FDA issued a Cleared decision on November 21, 2018, 26 days after receiving the submission on October 26, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5400.

Submission Details

510(k) Number K182977 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2018
Decision Date November 21, 2018
Days to Decision 26 days
Submission Type Special
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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