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FDA 510(k)

UL UHD-Clear View 4K Camera System (UL-3Chip 4K)

K-Number: K250462 · 2025-08-11

ApplicantUnivlabs Technologies Private Limited
Decision Date2025-08-11
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UL UHD-Clear View 4K Camera System (UL-3Chip 4K) is a medical device manufactured by Univlabs Technologies Private Limited. It received FDA 510(k) clearance on 2025-08-11 under approval number K250462. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UL UHD-Clear View 4K Camera System (UL-3Chip 4K)?

UL UHD-Clear View 4K Camera System (UL-3Chip 4K) is a medical device that received FDA 510(k) clearance on 2025-08-11. It is manufactured by Univlabs Technologies Private Limited. The 510(k) number is K250462.

When was UL UHD-Clear View 4K Camera System (UL-3Chip 4K) approved by the FDA?

UL UHD-Clear View 4K Camera System (UL-3Chip 4K) received FDA 510(k) clearance on 2025-08-11, under approval number K250462.

What company makes UL UHD-Clear View 4K Camera System (UL-3Chip 4K)?

UL UHD-Clear View 4K Camera System (UL-3Chip 4K) is manufactured by Univlabs Technologies Private Limited.

What is the FDA product code for UL UHD-Clear View 4K Camera System (UL-3Chip 4K)?

The FDA product code for UL UHD-Clear View 4K Camera System (UL-3Chip 4K) is FET.

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Related PubMed Literature

PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021) PMID: 31472187 A translational framework for peripheral nerve stimulating electrodes: Reviewing the journey from concept to clinic. Journal of neuroscience methods (2019)

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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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