MC1 Plus— 510(k) K161502

Substantially Equivalent

General Project S.R.L.

FDA 510(k) clearance K161502 for MC1 Plus, Substantially Equivalent on 2016-08-16. Applicant: General Project S.R.L.. Device class: 2.

Clearance details

Applicant: General Project S.R.L.
Product code: Code IMI
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 2016-06-01
Decision date: 2016-08-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Montespertoli, IT

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.