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FDA 510(k)

ROSA ONE Brain Application

K-Number: K182417 · 2019-02-07

ApplicantMedtech S.A
Decision Date2019-02-07
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ROSA ONE Brain Application is a medical device manufactured by Medtech S.A. It received FDA 510(k) clearance on 2019-02-07 under approval number K182417. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROSA ONE Brain Application?

ROSA ONE Brain Application is a medical device that received FDA 510(k) clearance on 2019-02-07. It is manufactured by Medtech S.A. The 510(k) number is K182417.

When was ROSA ONE Brain Application approved by the FDA?

ROSA ONE Brain Application received FDA 510(k) clearance on 2019-02-07, under approval number K182417.

What company makes ROSA ONE Brain Application?

ROSA ONE Brain Application is manufactured by Medtech S.A.

What is the FDA product code for ROSA ONE Brain Application?

The FDA product code for ROSA ONE Brain Application is HAW.

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Other Devices by Medtech S.A

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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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