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FDA 510(k)

EVOMATIC 8000/4000

K-Number: K843815 · 1985-05-31

ApplicantDantec Electronics, Inc.
Decision Date1985-05-31
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EVOMATIC 8000/4000 is the device name listed in this FDA 510(k) record. The listed applicant is Dantec Electronics, Inc.. It received FDA 510(k) clearance on 1985-05-31 under 510(k) number K843815. 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 EVOMATIC 8000/4000?

EVOMATIC 8000/4000 is a medical device that received FDA 510(k) clearance on 1985-05-31. The listed applicant is Dantec Electronics, Inc.. The 510(k) number is K843815.

When did EVOMATIC 8000/4000 receive FDA 510(k) clearance?

EVOMATIC 8000/4000 received FDA 510(k) clearance on 1985-05-31, under 510(k) number K843815.

Who is the listed applicant for EVOMATIC 8000/4000?

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

What is the FDA product code for EVOMATIC 8000/4000?

The FDA product code for EVOMATIC 8000/4000 is GWF.

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Other records listing Dantec Electronics, Inc. as applicant

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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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