Boston 角膜移植，Type I Lucia
K号: K182986 · 2019-01-30
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决定日期2019-01-30
产品代码HQM
咨询委员会OP
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决定实质等同
器械摘要
Boston Keratoprosthesis, Type I Lucia is the device name listed in this FDA 510(k) record. The listed applicant is Massachusetts Eye and Ear Infirmary D/B/A Boston. It received FDA 510(k) clearance on 2019-01-30 under 510(k) number K182986. The device is classified under product code HQM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Boston Keratoprosthesis, Type I Lucia?
Boston Keratoprosthesis, Type I Lucia is a medical device that received FDA 510(k) clearance on 2019-01-30. The listed applicant is Massachusetts Eye and Ear Infirmary D/B/A Boston. The 510(k) number is K182986.
When did Boston Keratoprosthesis, Type I Lucia receive FDA 510(k) clearance?
Boston Keratoprosthesis, Type I Lucia received FDA 510(k) clearance on 2019-01-30, under 510(k) number K182986.
Who is the listed applicant for Boston Keratoprosthesis, Type I Lucia?
The FDA 510(k) record lists Massachusetts Eye and Ear Infirmary D/B/A Boston as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Boston Keratoprosthesis, Type I Lucia?
The FDA product code for Boston Keratoprosthesis, Type I Lucia is HQM.
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