FDA 510(k)

PSLT 用于 PASCAL Streamline

K号: K171488 · 2017-11-27

决定日期2017-11-27

产品代码HQF

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决定实质等同

器械摘要

PSLT for PASCAL Streamline is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Medical Laser Systems, Inc.. It received FDA 510(k) clearance on 2017-11-27 under 510(k) number K171488. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PSLT for PASCAL Streamline?

PSLT for PASCAL Streamline is a medical device that received FDA 510(k) clearance on 2017-11-27. The listed applicant is Topcon Medical Laser Systems, Inc.. The 510(k) number is K171488.

When did PSLT for PASCAL Streamline receive FDA 510(k) clearance?

PSLT for PASCAL Streamline received FDA 510(k) clearance on 2017-11-27, under 510(k) number K171488.

Who is the listed applicant for PSLT for PASCAL Streamline?

The FDA 510(k) record lists Topcon Medical Laser Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PSLT for PASCAL Streamline?

The FDA product code for PSLT for PASCAL Streamline is HQF.

列明Topcon Medical Laser Systems, Inc.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。

K180402PSLT 与 PASCAL Synthesis，PSLT 与 PASCAL Synthesis TwinStar

官方来源

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