iCodeConnect

FDA 510(k) K160127 · 3B Medical, Inc.

Substantially Equivalent

510(k) numberK160127

Submission

Device name
iCodeConnect
Applicant
3B Medical, Inc.
Winter Haven, FL, US
Received
January 20, 2016
Decision date
November 10, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BZD – Ventilator, Non-Continuous (Respirator)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5905
Specialty
Anesthesiology

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Questions and answers

When was iCodeConnect cleared by the FDA?

iCodeConnect (K160127) received a 510(k) decision of Substantially Equivalent on November 10, 2016, 295 days after the submission was received.

What is the product code of K160127?

The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.