FDA 510(k)

便携式牙科X射线（AXR60 S）；便携式牙科X射线（AXR65 S）

K号: K233395 · 2024-01-03

申请人Alliage S/A Industrias Médico Odontológica

决定日期2024-01-03

产品代码EHD

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决定实质等同

器械摘要

Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) is the device name listed in this FDA 510(k) record. The listed applicant is Alliage S/A Industrias Médico Odontológica. It received FDA 510(k) clearance on 2024-01-03 under 510(k) number K233395. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)?

Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) is a medical device that received FDA 510(k) clearance on 2024-01-03. The listed applicant is Alliage S/A Industrias Médico Odontológica. The 510(k) number is K233395.

When did Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) receive FDA 510(k) clearance?

Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) received FDA 510(k) clearance on 2024-01-03, under 510(k) number K233395.

Who is the listed applicant for Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)?

The FDA 510(k) record lists Alliage S/A Industrias Médico Odontológica as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)?

The FDA product code for Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) is EHD.

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。

便携式牙科X射线（AXR60 S）；便携式牙科X射线（AXR65 S）

器械摘要

常见问题

相关临床试验

相关器械（代码：EHD）

官方来源