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FDA 510(k)

IQQA-CHEST SOFTWARE PACKAGE

K-Number: K042408 · 2004-10-08

ApplicantEdda Technology, Inc.
Decision Date2004-10-08
Product CodeOMJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IQQA-CHEST SOFTWARE PACKAGE is the device name listed in this FDA 510(k) record. The listed applicant is Edda Technology, Inc.. It received FDA 510(k) clearance on 2004-10-08 under 510(k) number K042408. The device is classified under product code OMJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IQQA-CHEST SOFTWARE PACKAGE?

IQQA-CHEST SOFTWARE PACKAGE is a medical device that received FDA 510(k) clearance on 2004-10-08. The listed applicant is Edda Technology, Inc.. The 510(k) number is K042408.

When did IQQA-CHEST SOFTWARE PACKAGE receive FDA 510(k) clearance?

IQQA-CHEST SOFTWARE PACKAGE received FDA 510(k) clearance on 2004-10-08, under 510(k) number K042408.

Who is the listed applicant for IQQA-CHEST SOFTWARE PACKAGE?

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

What is the FDA product code for IQQA-CHEST SOFTWARE PACKAGE?

The FDA product code for IQQA-CHEST SOFTWARE PACKAGE is OMJ.

Related Clinical Trials

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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Other records listing Edda Technology, 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.

K131498IQQA-LIVER MULTIMODALITY SOFTWAREK061696IQQA-LIVER SOFTWARE

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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