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.
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Official Source
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