FDA 510(k)

E-Z SCAN AB5500+

K-Number: K040668 · 2004-04-13

Decision Date2004-04-13

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

E-Z SCAN AB5500+ is the device name listed in this FDA 510(k) record. The listed applicant is Sonomed, Inc.. It received FDA 510(k) clearance on 2004-04-13 under 510(k) number K040668. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-Z SCAN AB5500+?

E-Z SCAN AB5500+ is a medical device that received FDA 510(k) clearance on 2004-04-13. The listed applicant is Sonomed, Inc.. The 510(k) number is K040668.

When did E-Z SCAN AB5500+ receive FDA 510(k) clearance?

E-Z SCAN AB5500+ received FDA 510(k) clearance on 2004-04-13, under 510(k) number K040668.

Who is the listed applicant for E-Z SCAN AB5500+?

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

What is the FDA product code for E-Z SCAN AB5500+?

The FDA product code for E-Z SCAN AB5500+ is IYO.

Other records listing Sonomed, 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.

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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.