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FDA 510(k)

GEM-6, WITH COMPONENTS

K-Number: K854357 · 1986-01-08

ApplicantDiamond Electro-Tech, Inc.
Decision Date1986-01-08
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GEM-6, WITH COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Diamond Electro-Tech, Inc.. It received FDA 510(k) clearance on 1986-01-08 under 510(k) number K854357. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEM-6, WITH COMPONENTS?

GEM-6, WITH COMPONENTS is a medical device that received FDA 510(k) clearance on 1986-01-08. The listed applicant is Diamond Electro-Tech, Inc.. The 510(k) number is K854357.

When did GEM-6, WITH COMPONENTS receive FDA 510(k) clearance?

GEM-6, WITH COMPONENTS received FDA 510(k) clearance on 1986-01-08, under 510(k) number K854357.

Who is the listed applicant for GEM-6, WITH COMPONENTS?

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

What is the FDA product code for GEM-6, WITH COMPONENTS?

The FDA product code for GEM-6, WITH COMPONENTS is DRY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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