DUOFLEX COIL SUITE (1.5T)— 510(k) K130706

Clearance details

Applicant

Mr Instruments, Inc.

Product code

Code MOS

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2013-03-15

Decision date

2013-07-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Minneapolis, MN, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130706.