FDA 510(k)

MC1 Plus

K-Number: K161502 · 2016-08-16

Decision Date2016-08-16

Product CodeIMI

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

MC1 Plus is the device name listed in this FDA 510(k) record. The listed applicant is General Project S.R.L.. It received FDA 510(k) clearance on 2016-08-16 under 510(k) 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. The listed applicant is General Project S.R.L.. The 510(k) number is K161502.

When did MC1 Plus receive FDA 510(k) clearance?

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

Who is the listed applicant for MC1 Plus?

The FDA 510(k) record lists General Project S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MC1 Plus?

The FDA product code for MC1 Plus is IMI.

Related Devices (Code: IMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240788Ultrasound StimulatorJkh Health Co., Ltd.K230472Sonopuls 190Enraf-Nonius, B.V.K222098ManaSport+Manamed, Inc.K210284ManaSportManamed, Inc.K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E Orto K160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , Ltd.

Official Source

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