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FDA 510(k)

THE IC-PRO SYSTEM

K-Number: K110256 · 2011-05-27

ApplicantPaieon, Inc.
Decision Date2011-05-27
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE IC-PRO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Paieon, Inc.. It received FDA 510(k) clearance on 2011-05-27 under 510(k) number K110256. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE IC-PRO SYSTEM?

THE IC-PRO SYSTEM is a medical device that received FDA 510(k) clearance on 2011-05-27. The listed applicant is Paieon, Inc.. The 510(k) number is K110256.

When did THE IC-PRO SYSTEM receive FDA 510(k) clearance?

THE IC-PRO SYSTEM received FDA 510(k) clearance on 2011-05-27, under 510(k) number K110256.

Who is the listed applicant for THE IC-PRO SYSTEM?

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

What is the FDA product code for THE IC-PRO SYSTEM?

The FDA product code for THE IC-PRO SYSTEM is IZI.

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Other records listing Paieon, 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.

K120282CARDNAVK113594C-THV SYSTEMK083745THE IC-PRO SYSTEM, MODEL VERSION 3.2K082907IC-PRO SYSTEM, VERSION 3.1.0.4K073328CARDIOP-B SYSTEM, VERSION 2.1 WITH LVAK072591CARDIOP-B SYSTEM, VERSION 2.1

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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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