FDA 510(k)

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

K番号: K250462 · 2025-08-11

申請者Univlabs Technologies Private Limited

決定日2025-08-11

製品コードFET

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定Substantially Equivalent

医療機器の概要

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.

よくある質問

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.

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

医療機器の概要

よくある質問

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