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FDA 510(k)

THE IC-PRO SYSTEM, MODEL VERSION 3.2

K-Number: K083745 · 2009-02-17

ApplicantPaieon, Inc.
Decision Date2009-02-17
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE IC-PRO SYSTEM, MODEL VERSION 3.2 is the device name listed in this FDA 510(k) record. The listed applicant is Paieon, Inc.. It received FDA 510(k) clearance on 2009-02-17 under 510(k) number K083745. 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, MODEL VERSION 3.2?

THE IC-PRO SYSTEM, MODEL VERSION 3.2 is a medical device that received FDA 510(k) clearance on 2009-02-17. The listed applicant is Paieon, Inc.. The 510(k) number is K083745.

When did THE IC-PRO SYSTEM, MODEL VERSION 3.2 receive FDA 510(k) clearance?

THE IC-PRO SYSTEM, MODEL VERSION 3.2 received FDA 510(k) clearance on 2009-02-17, under 510(k) number K083745.

Who is the listed applicant for THE IC-PRO SYSTEM, MODEL VERSION 3.2?

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, MODEL VERSION 3.2?

The FDA product code for THE IC-PRO SYSTEM, MODEL VERSION 3.2 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 SYSTEMK110256THE IC-PRO SYSTEMK082907IC-PRO SYSTEM, VERSION 3.1.0.4K073328CARDIOP-B SYSTEM, VERSION 2.1 WITH LVAK072591CARDIOP-B SYSTEM, VERSION 2.1

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Related Devices (Code: IZI)

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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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