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FDA 510(k)

MC1 Plus

K-Number: K161502 · 2016-08-16

ApplicantGeneral Project S.R.L.
Decision Date2016-08-16
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MC1 Plus is a medical device manufactured by General Project S.R.L.. It received FDA 510(k) clearance on 2016-08-16 under approval number K161502. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MC1 Plus?

MC1 Plus is a medical device that received FDA 510(k) clearance on 2016-08-16. It is manufactured by General Project S.R.L.. The 510(k) number is K161502.

When was MC1 Plus approved by the FDA?

MC1 Plus received FDA 510(k) clearance on 2016-08-16, under approval number K161502.

What company makes MC1 Plus?

MC1 Plus is manufactured by General Project S.R.L..

What is the FDA product code for MC1 Plus?

The FDA product code for MC1 Plus is IMI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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