FDA 510(k)

WEB1000

K-Number: K053458 · 2005-12-22

Decision Date2005-12-22

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

WEB1000 is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Corp.. It received FDA 510(k) clearance on 2005-12-22 under 510(k) number K053458. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WEB1000?

WEB1000 is a medical device that received FDA 510(k) clearance on 2005-12-22. The listed applicant is Agfa Corp.. The 510(k) number is K053458.

When did WEB1000 receive FDA 510(k) clearance?

WEB1000 received FDA 510(k) clearance on 2005-12-22, under 510(k) number K053458.

Who is the listed applicant for WEB1000?

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

What is the FDA product code for WEB1000?

The FDA product code for WEB1000 is LLZ.

Other records listing Agfa Corp. 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.

K063421DX-SI K050751IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X K050810AGFA CR50.0 K042779RADIOTHERAPY SOLUTION BASED ON CR K041701AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM K040555IMPAX CLIENT EMBRACE

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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.