用于黑色素瘤检测的光学诊断设备
PMA编号：P090012 · 2016-08-18
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决定日期2016-08-18
PMA 编号P090012
产品代码OYD
设备分类第2类
医疗专科G
法规编号21 CFR 8
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
器械摘要
Optical diagnostic device for melanoma detection is the device name listed in this FDA 510(k) record. The listed applicant is Strata Skin Sciences, Inc.. It received FDA 510(k) clearance on 2016-08-18. The device is classified under product code OYD. It was reviewed by the SU advisory panel.
常见问题
What is the Optical diagnostic device for melanoma detection?
Optical diagnostic device for melanoma detection is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is Strata Skin Sciences, Inc..
When did Optical diagnostic device for melanoma detection receive FDA 510(k) clearance?
The clearance date for Optical diagnostic device for melanoma detection can be found in the official FDA records.
Who is the listed applicant for Optical diagnostic device for melanoma detection?
The FDA 510(k) record lists Strata Skin Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Optical diagnostic device for melanoma detection?
The FDA product code for Optical diagnostic device for melanoma detection is OYD.
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官方来源
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