FDA 510(k)

21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)

K番号: K233336 · 2024-05-21

決定日2024-05-21

製品コードPGY

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) is the device name listed in this FDA 510(k) record. The listed applicant is Acula Technology Corp.. It received FDA 510(k) clearance on 2024-05-21 under 510(k) number K233336. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)?

21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) is a medical device that received FDA 510(k) clearance on 2024-05-21. The listed applicant is Acula Technology Corp.. The 510(k) number is K233336.

When did 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) receive FDA 510(k) clearance?

21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) received FDA 510(k) clearance on 2024-05-21, under 510(k) number K233336.

Who is the listed applicant for 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)?

The FDA 510(k) record lists Acula Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)?

The FDA product code for 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) is PGY.

申請者としてAcula Technology Corp.を記載するその他の記録

K24149921.3” 5MP Color LCD Display UMD5-21B01

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