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FDA 510(k)

IONOFIL COLOR AC

K-Number: K033068 · 2003-10-31

ApplicantVoco GmbH
Decision Date2003-10-31
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IONOFIL COLOR AC is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2003-10-31 under 510(k) number K033068. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IONOFIL COLOR AC?

IONOFIL COLOR AC is a medical device that received FDA 510(k) clearance on 2003-10-31. The listed applicant is Voco GmbH. The 510(k) number is K033068.

When did IONOFIL COLOR AC receive FDA 510(k) clearance?

IONOFIL COLOR AC received FDA 510(k) clearance on 2003-10-31, under 510(k) number K033068.

Who is the listed applicant for IONOFIL COLOR AC?

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

What is the FDA product code for IONOFIL COLOR AC?

The FDA product code for IONOFIL COLOR AC is EMA.

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Related Devices (Code: EMA)

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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