Smart One— 510(k) K181666

Substantially Equivalent

Mir Medical International Research

FDA 510(k) clearance K181666 for Smart One, Substantially Equivalent on 2018-08-01. Applicant: Mir Medical International Research. Device class: 2.

Clearance details

Applicant
Mir Medical International Research
Product code
Code BZH
Device class
Class 2
Regulation
21 CFR 868.1860
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Roma, IT
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