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FDA 510(k)

ESP7 VENOUS IMAGE

K-Number: K982612 · 1998-12-14

ApplicantIronmaster, Inc.
Decision Date1998-12-14
Product CodeKZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ESP7 VENOUS IMAGE is the device name listed in this FDA 510(k) record. The listed applicant is Ironmaster, Inc.. It received FDA 510(k) clearance on 1998-12-14 under 510(k) number K982612. The device is classified under product code KZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESP7 VENOUS IMAGE?

ESP7 VENOUS IMAGE is a medical device that received FDA 510(k) clearance on 1998-12-14. The listed applicant is Ironmaster, Inc.. The 510(k) number is K982612.

When did ESP7 VENOUS IMAGE receive FDA 510(k) clearance?

ESP7 VENOUS IMAGE received FDA 510(k) clearance on 1998-12-14, under 510(k) number K982612.

Who is the listed applicant for ESP7 VENOUS IMAGE?

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

What is the FDA product code for ESP7 VENOUS IMAGE?

The FDA product code for ESP7 VENOUS IMAGE is KZA.

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Related Devices (Code: KZA)

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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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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