NOX T3, NOXTURNAL (PC APPLICATION)— 510(k) K082113

Clearance details

Applicant

Nox Medical

Product code

Code MNR

Device class

Class 2

Regulation

21 CFR 868.2375

Advisory panel

Anesthesiology

Date received

2008-07-28

Decision date

2008-11-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Reykjavik, IS

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082113.