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FDA 510(k)

DANTEC EVOLUTION

K-Number: K924127 · 1993-03-10

ApplicantDantec Medical, Inc.
Decision Date1993-03-10
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DANTEC EVOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Dantec Medical, Inc.. It received FDA 510(k) clearance on 1993-03-10 under 510(k) number K924127. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANTEC EVOLUTION?

DANTEC EVOLUTION is a medical device that received FDA 510(k) clearance on 1993-03-10. The listed applicant is Dantec Medical, Inc.. The 510(k) number is K924127.

When did DANTEC EVOLUTION receive FDA 510(k) clearance?

DANTEC EVOLUTION received FDA 510(k) clearance on 1993-03-10, under 510(k) number K924127.

Who is the listed applicant for DANTEC EVOLUTION?

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

What is the FDA product code for DANTEC EVOLUTION?

The FDA product code for DANTEC EVOLUTION is GWF.

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Other records listing Dantec Medical, 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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Related Devices (Code: GWF)

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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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