rTOP
K号: K243333 · 2025-02-04
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器械摘要
rTOP is the device name listed in this FDA 510(k) record. The listed applicant is Roclub GmbH. It received FDA 510(k) clearance on 2025-02-04 under 510(k) number K243333. 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 rTOP?
rTOP is a medical device that received FDA 510(k) clearance on 2025-02-04. The listed applicant is Roclub GmbH. The 510(k) number is K243333.
When did rTOP receive FDA 510(k) clearance?
rTOP received FDA 510(k) clearance on 2025-02-04, under 510(k) number K243333.
Who is the listed applicant for rTOP?
The FDA 510(k) record lists Roclub GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for rTOP?
The FDA product code for rTOP is LLZ.
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
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