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FDA 510(k)

CLINDATALINK VERSION 1.0 FOR SPIROMETRY

K-Number: K020004 · 2002-07-24

Decision Date2002-07-24
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CLINDATALINK VERSION 1.0 FOR SPIROMETRY is the device name listed in this FDA 510(k) record. The listed applicant is Compleware Corp.. It received FDA 510(k) clearance on 2002-07-24 under 510(k) number K020004. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINDATALINK VERSION 1.0 FOR SPIROMETRY?

CLINDATALINK VERSION 1.0 FOR SPIROMETRY is a medical device that received FDA 510(k) clearance on 2002-07-24. The listed applicant is Compleware Corp.. The 510(k) number is K020004.

When did CLINDATALINK VERSION 1.0 FOR SPIROMETRY receive FDA 510(k) clearance?

CLINDATALINK VERSION 1.0 FOR SPIROMETRY received FDA 510(k) clearance on 2002-07-24, under 510(k) number K020004.

Who is the listed applicant for CLINDATALINK VERSION 1.0 FOR SPIROMETRY?

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

What is the FDA product code for CLINDATALINK VERSION 1.0 FOR SPIROMETRY?

The FDA product code for CLINDATALINK VERSION 1.0 FOR SPIROMETRY is BZG.

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.

Related Devices (Code: BZG)

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.

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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