Deroyal Industries, Inc. Defogger
FDA 510(k) K982465 · Deroyal Industries, Inc.
510(k) numberK982465
Submission
- Device name
- Deroyal Industries, Inc. Defogger
- Applicant
- Deroyal Industries, Inc.
Powell, TN, US - Received
- July 15, 1998
- Decision date
- August 11, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCT – Anti Fog Solution And Accessories, Endoscopy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To prevent, reduce or eliminate condensation (fog) on endoscopic lens.
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| K111622 | Unimax Anti-Fog SolutionOCT · Traditional | Unimax Medical Systems, Inc. | 09/09/2011SE |
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Questions and answers
When was Deroyal Industries, Inc. Defogger cleared by the FDA?
Deroyal Industries, Inc. Defogger (K982465) received a 510(k) decision of Substantially Equivalent on August 11, 1998, 27 days after the submission was received.
What is the product code of K982465?
The FDA product code is OCT – Anti Fog Solution And Accessories, Endoscopy, a Class II (moderate risk) device regulated under 21 CFR 876.1500.