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FDA 510(k)

DEROYAL INDUSTRIES, INC. DEFOGGER

K-Number: K982465 · 1998-08-11

ApplicantDeroyal Industries, Inc.
Decision Date1998-08-11
Product CodeOCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEROYAL INDUSTRIES, INC. DEFOGGER is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1998-08-11 under 510(k) number K982465. The device is classified under product code OCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEROYAL INDUSTRIES, INC. DEFOGGER?

DEROYAL INDUSTRIES, INC. DEFOGGER is a medical device that received FDA 510(k) clearance on 1998-08-11. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K982465.

When did DEROYAL INDUSTRIES, INC. DEFOGGER receive FDA 510(k) clearance?

DEROYAL INDUSTRIES, INC. DEFOGGER received FDA 510(k) clearance on 1998-08-11, under 510(k) number K982465.

Who is the listed applicant for DEROYAL INDUSTRIES, INC. DEFOGGER?

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

What is the FDA product code for DEROYAL INDUSTRIES, INC. DEFOGGER?

The FDA product code for DEROYAL INDUSTRIES, INC. DEFOGGER is OCT.

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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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