Cleared Traditional

K141565 - GLOBE-TROTTER GT5400
(FDA 510(k) Clearance)

K141565 · Draeger Medical Systems, Inc. · General Hospital
Sep 2014
Decision
90d
Days
Class 2
Risk

K141565 is an FDA 510(k) clearance for the GLOBE-TROTTER GT5400. This device is classified as a Incubator, Neonatal Transport (Class II — Special Controls, product code FPL).

Submitted by Draeger Medical Systems, Inc. (Telford, US). The FDA issued a Cleared decision on September 10, 2014, 90 days after receiving the submission on June 12, 2014.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5410.

Submission Details

510(k) Number K141565 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2014
Decision Date September 10, 2014
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPL — Incubator, Neonatal Transport
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5410

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