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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 the device name listed in this FDA 510(k) record. The listed applicant is Univlabs Technologies Private Limited. It received FDA 510(k) clearance on 2025-08-11 under 510(k) 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. The listed applicant is Univlabs Technologies Private Limited. The 510(k) number is K250462.

When did UL UHD-Clear View 4K Camera System (UL-3Chip 4K) receive FDA 510(k) clearance?

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

Who is the listed applicant for UL UHD-Clear View 4K Camera System (UL-3Chip 4K)?

The FDA 510(k) record lists Univlabs Technologies Private Limited as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: FET)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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