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FDA 510(k)

MAKO 7

K-Number: K182975 · 2019-05-21

ApplicantBoston Scientific Corporation
Decision Date2019-05-21
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MAKO 7 is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-05-21 under approval number K182975. 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 2019-05-21. It is manufactured by Boston Scientific Corporation. The 510(k) number is K182975.

When was MAKO 7 approved by the FDA?

MAKO 7 received FDA 510(k) clearance on 2019-05-21, under approval number K182975.

What company makes MAKO 7?

MAKO 7 is manufactured by Boston Scientific 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

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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