FDA 510(k)

SOTAクラウドイメージング

K番号: K210682 · 2021-05-04

申請者Sota Precision Optics, Inc. Dba Sota Imaging

決定日2021-05-04

製品コードLLZ

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

SOTA Cloud Imaging is the device name listed in this FDA 510(k) record. The listed applicant is Sota Precision Optics, Inc. Dba Sota Imaging. It received FDA 510(k) clearance on 2021-05-04 under 510(k) number K210682. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the SOTA Cloud Imaging?

SOTA Cloud Imaging is a medical device that received FDA 510(k) clearance on 2021-05-04. The listed applicant is Sota Precision Optics, Inc. Dba Sota Imaging. The 510(k) number is K210682.

When did SOTA Cloud Imaging receive FDA 510(k) clearance?

SOTA Cloud Imaging received FDA 510(k) clearance on 2021-05-04, under 510(k) number K210682.

Who is the listed applicant for SOTA Cloud Imaging?

The FDA 510(k) record lists Sota Precision Optics, Inc. Dba Sota Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOTA Cloud Imaging?

The FDA product code for SOTA Cloud Imaging is LLZ.

申請者としてSota Precision Optics, Inc. Dba Sota Imagingを記載するその他の記録

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