Presero 3D扫描系统
K号: K190074 · 2019-02-14
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器械摘要
Presero 3D Scanning System is the device name listed in this FDA 510(k) record. The listed applicant is Certis Health. It received FDA 510(k) clearance on 2019-02-14 under 510(k) number K190074. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Presero 3D Scanning System?
Presero 3D Scanning System is a medical device that received FDA 510(k) clearance on 2019-02-14. The listed applicant is Certis Health. The 510(k) number is K190074.
When did Presero 3D Scanning System receive FDA 510(k) clearance?
Presero 3D Scanning System received FDA 510(k) clearance on 2019-02-14, under 510(k) number K190074.
Who is the listed applicant for Presero 3D Scanning System?
The FDA 510(k) record lists Certis Health as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Presero 3D Scanning System?
The FDA product code for Presero 3D Scanning System is LLZ.
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相关器械（代码：LLZ）
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请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。Taiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC
官方来源
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