FDA 510(k)

Perimeter Otis™ 1.0 光相干断层扫描系统

K号: K160240 · 2016-05-13

决定日期2016-05-13

产品代码NQQ

咨询委员会RA

决定Unknown

器械摘要

Perimeter Otis™ 1.0 Optical Coherence Tomography System is the device name listed in this FDA 510(k) record. The listed applicant is Perimeter Medical Imaging, Inc.. It received FDA 510(k) clearance on 2016-05-13 under 510(k) number K160240. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Unknown.

常见问题

What is the Perimeter Otis™ 1.0 Optical Coherence Tomography System?

Perimeter Otis™ 1.0 Optical Coherence Tomography System is a medical device that received FDA 510(k) clearance on 2016-05-13. The listed applicant is Perimeter Medical Imaging, Inc.. The 510(k) number is K160240.

When did Perimeter Otis™ 1.0 Optical Coherence Tomography System receive FDA 510(k) clearance?

Perimeter Otis™ 1.0 Optical Coherence Tomography System received FDA 510(k) clearance on 2016-05-13, under 510(k) number K160240.

Who is the listed applicant for Perimeter Otis™ 1.0 Optical Coherence Tomography System?

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

What is the FDA product code for Perimeter Otis™ 1.0 Optical Coherence Tomography System?

The FDA product code for Perimeter Otis™ 1.0 Optical Coherence Tomography System is NQQ.

列明Perimeter Medical Imaging, 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。

K190404OTIS 光相干断层扫描系统 K171560OTIS 光相干断层扫描系统

官方来源

在 FDA 数据库中查看 →

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。