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FDA 510(k)

iCodeConnect

K-Number: K160127 · 2016-11-10

Applicant3B Medical, Inc.
Decision Date2016-11-10
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

iCodeConnect is a medical device manufactured by 3B Medical, Inc.. It received FDA 510(k) clearance on 2016-11-10 under approval number K160127. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iCodeConnect?

iCodeConnect is a medical device that received FDA 510(k) clearance on 2016-11-10. It is manufactured by 3B Medical, Inc.. The 510(k) number is K160127.

When was iCodeConnect approved by the FDA?

iCodeConnect received FDA 510(k) clearance on 2016-11-10, under approval number K160127.

What company makes iCodeConnect?

iCodeConnect is manufactured by 3B Medical, Inc..

What is the FDA product code for iCodeConnect?

The FDA product code for iCodeConnect is BZD.

Other Devices by 3B Medical, Inc.

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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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