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FDA 510(k)

TBS iNsight

K-Number: K152299 · 2016-04-29

ApplicantMedimaps Group SA
Decision Date2016-04-29
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TBS iNsight is a medical device manufactured by Medimaps Group SA. It received FDA 510(k) clearance on 2016-04-29 under approval number K152299. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TBS iNsight?

TBS iNsight is a medical device that received FDA 510(k) clearance on 2016-04-29. It is manufactured by Medimaps Group SA. The 510(k) number is K152299.

When was TBS iNsight approved by the FDA?

TBS iNsight received FDA 510(k) clearance on 2016-04-29, under approval number K152299.

What company makes TBS iNsight?

TBS iNsight is manufactured by Medimaps Group SA.

What is the FDA product code for TBS iNsight?

The FDA product code for TBS iNsight is KGI.

Other Devices by Medimaps Group SA

K243218TBS iNsight (V4)

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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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