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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 the device name listed in this FDA 510(k) record. The listed applicant is 3B Medical, Inc.. It received FDA 510(k) clearance on 2016-11-10 under 510(k) 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. The listed applicant is 3B Medical, Inc.. The 510(k) number is K160127.

When did iCodeConnect receive FDA 510(k) clearance?

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

Who is the listed applicant for iCodeConnect?

The FDA 510(k) record lists 3B Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iCodeConnect?

The FDA product code for iCodeConnect is BZD.

Other records listing 3B Medical, Inc. as applicant

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Related Devices (Code: BZD)

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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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