FDA 510(k)

sam X1 长效超声设备

K号: K211513 · 2021-08-18

决定日期2021-08-18

产品代码PFW

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决定实质等同

器械摘要

sam X1 Long Duration Ultrasound Device is the device name listed in this FDA 510(k) record. The listed applicant is ZetrOZ Systems, LLC. It received FDA 510(k) clearance on 2021-08-18 under 510(k) number K211513. The device is classified under product code PFW. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the sam X1 Long Duration Ultrasound Device?

sam X1 Long Duration Ultrasound Device is a medical device that received FDA 510(k) clearance on 2021-08-18. The listed applicant is ZetrOZ Systems, LLC. The 510(k) number is K211513.

When did sam X1 Long Duration Ultrasound Device receive FDA 510(k) clearance?

sam X1 Long Duration Ultrasound Device received FDA 510(k) clearance on 2021-08-18, under 510(k) number K211513.

Who is the listed applicant for sam X1 Long Duration Ultrasound Device?

The FDA 510(k) record lists ZetrOZ Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for sam X1 Long Duration Ultrasound Device?

The FDA product code for sam X1 Long Duration Ultrasound Device is PFW.

列明ZetrOZ Systems, LLC为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260076SAM 3.0 多小时连续超声设备 K233210sam CS 长时超声设备 K223019sam 2.0 长距离超声设备 K191568sam 2.0 长时超声系统

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。