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FDA 510(k)

MAKO 7

K-Number: K160510 · 2016-06-09

ApplicantNvision Medical Corporation
Decision Date2016-06-09
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MAKO 7 is a medical device manufactured by Nvision Medical Corporation. It received FDA 510(k) clearance on 2016-06-09 under approval number K160510. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAKO 7?

MAKO 7 is a medical device that received FDA 510(k) clearance on 2016-06-09. It is manufactured by Nvision Medical Corporation. The 510(k) number is K160510.

When was MAKO 7 approved by the FDA?

MAKO 7 received FDA 510(k) clearance on 2016-06-09, under approval number K160510.

What company makes MAKO 7?

MAKO 7 is manufactured by Nvision Medical Corporation.

What is the FDA product code for MAKO 7?

The FDA product code for MAKO 7 is HIH.

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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.

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