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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 the device name listed in this FDA 510(k) record. The listed applicant is Nvision Medical Corporation. It received FDA 510(k) clearance on 2016-06-09 under 510(k) 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. The listed applicant is Nvision Medical Corporation. The 510(k) number is K160510.

When did MAKO 7 receive FDA 510(k) clearance?

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

Who is the listed applicant for MAKO 7?

The FDA 510(k) record lists Nvision Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAKO 7?

The FDA product code for MAKO 7 is HIH.

Related Devices (Code: HIH)

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.

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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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