FDA 510(k)

CARDIQ FUNCTION XPRESS

K-Number: K073153 · 2008-02-26

Decision Date2008-02-26

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CARDIQ FUNCTION XPRESS is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems SCS. It received FDA 510(k) clearance on 2008-02-26 under 510(k) number K073153. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIQ FUNCTION XPRESS?

CARDIQ FUNCTION XPRESS is a medical device that received FDA 510(k) clearance on 2008-02-26. The listed applicant is GE Medical Systems SCS. The 510(k) number is K073153.

When did CARDIQ FUNCTION XPRESS receive FDA 510(k) clearance?

CARDIQ FUNCTION XPRESS received FDA 510(k) clearance on 2008-02-26, under 510(k) number K073153.

Who is the listed applicant for CARDIQ FUNCTION XPRESS?

The FDA 510(k) record lists GE Medical Systems SCS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIQ FUNCTION XPRESS?

The FDA product code for CARDIQ FUNCTION XPRESS is JAK.

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Other records listing GE Medical Systems SCS as applicant

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Related Devices (Code: JAK)

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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.