FDA 510(k)

OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D

K号: K160405 · 2017-10-20

申请人Ptw-Freiburg Physikalisch-Technische-Werkstaetten

决定日期2017-10-20

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D is the device name listed in this FDA 510(k) record. The listed applicant is Ptw-Freiburg Physikalisch-Technische-Werkstaetten. It received FDA 510(k) clearance on 2017-10-20 under 510(k) number K160405. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D?

OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D is a medical device that received FDA 510(k) clearance on 2017-10-20. The listed applicant is Ptw-Freiburg Physikalisch-Technische-Werkstaetten. The 510(k) number is K160405.

When did OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D receive FDA 510(k) clearance?

OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D received FDA 510(k) clearance on 2017-10-20, under 510(k) number K160405.

Who is the listed applicant for OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D?

The FDA 510(k) record lists Ptw-Freiburg Physikalisch-Technische-Werkstaetten as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D?

The FDA product code for OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D is IYE.

列明Ptw-Freiburg Physikalisch-Technische-Werkstaetten为申报人的其他记录

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K213370设备名称：VERIQA 医疗设备监管文本翻译：设备名称：VERIQA 产品名称：[保留产品名称] 公司名称：[保留公司名称] FDA（美国食品药品监督管理局）：美国食品药品监督管理局 510(k)：510(k)申请 PMA：上市前批准 NCT：临床试验注册号 PMID：PubMed ID 标识符：[保留标识符] URL：[保留URL] 请注意，以上翻译保留了原文中的专有名词和缩写。K191646Beamscan MR

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