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FDA 510(k)

iC-GN iC-Cassette for use on the iC-System

K-Number: K190341 · 2019-06-28

ApplicantIcubate, Inc.
Decision Date2019-06-28
Product CodePEN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

iC-GN iC-Cassette for use on the iC-System is the device name listed in this FDA 510(k) record. The listed applicant is Icubate, Inc.. It received FDA 510(k) clearance on 2019-06-28 under 510(k) number K190341. The device is classified under product code PEN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iC-GN iC-Cassette for use on the iC-System?

iC-GN iC-Cassette for use on the iC-System is a medical device that received FDA 510(k) clearance on 2019-06-28. The listed applicant is Icubate, Inc.. The 510(k) number is K190341.

When did iC-GN iC-Cassette for use on the iC-System receive FDA 510(k) clearance?

iC-GN iC-Cassette for use on the iC-System received FDA 510(k) clearance on 2019-06-28, under 510(k) number K190341.

Who is the listed applicant for iC-GN iC-Cassette for use on the iC-System?

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

What is the FDA product code for iC-GN iC-Cassette for use on the iC-System?

The FDA product code for iC-GN iC-Cassette for use on the iC-System is PEN.

Other records listing Icubate, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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