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510(k) Data Aggregation
K Number
K981821Device Name
VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATORManufacturer
Date Cleared
1998-07-29
(68 days)
Product Code
Regulation Number
878.4580Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The VES 3001/w use is indicated in the following situations:
- Whenever there is a need for head lamp illumination of the fiber-optic type .
- When ever there is a need for a fiber-optic illuminator for an endoscope .
- . When ever there is a need to use video either as a visual aid for as a method of recording or both.
- When ever there is a requirement for any or all of the above at the same . time.
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called the "VES 3001/2 Dual Output Video Illuminator."
This document does not contain the kind of information requested in your prompt regarding acceptance criteria, a study proving device performance, sample sizes, expert qualifications, ground truth methods, or details about training sets. The letter is a regulatory approval document confirming substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information from this text.
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