PRE-SURE
K号: K201835 · 2021-07-08
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器械摘要
PRE-SURE is the device name listed in this FDA 510(k) record. The listed applicant is Lazarus 3D, Inc.. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K201835. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PRE-SURE?
PRE-SURE is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is Lazarus 3D, Inc.. The 510(k) number is K201835.
When did PRE-SURE receive FDA 510(k) clearance?
PRE-SURE received FDA 510(k) clearance on 2021-07-08, under 510(k) number K201835.
Who is the listed applicant for PRE-SURE?
The FDA 510(k) record lists Lazarus 3D, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PRE-SURE?
The FDA product code for PRE-SURE is LLZ.
相关器械（代码：LLZ）
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官方来源
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