GLOBE-TROTTER GT5400— 510(k) K141565

Clearance details

Applicant

Draeger Medical Systems, Inc.

Product code

Code FPL

Device class

Class 2

Regulation

21 CFR 880.5410

Advisory panel

General Hospital

Date received

2014-06-12

Decision date

2014-09-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Telford, PA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141565.