FDA 510(k)

CyMedica e-vive™ 系统；CY-1000

K号: K163067 · 2016-12-01

决定日期2016-12-01

产品代码IPF

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决定实质等同

器械摘要

CyMedica e-vive™ System; CY-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Cymedica Orthopedics, Inc.. It received FDA 510(k) clearance on 2016-12-01 under 510(k) number K163067. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CyMedica e-vive™ System; CY-1000?

CyMedica e-vive™ System; CY-1000 is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Cymedica Orthopedics, Inc.. The 510(k) number is K163067.

When did CyMedica e-vive™ System; CY-1000 receive FDA 510(k) clearance?

CyMedica e-vive™ System; CY-1000 received FDA 510(k) clearance on 2016-12-01, under 510(k) number K163067.

Who is the listed applicant for CyMedica e-vive™ System; CY-1000?

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

What is the FDA product code for CyMedica e-vive™ System; CY-1000?

The FDA product code for CyMedica e-vive™ System; CY-1000 is IPF.

列明Cymedica Orthopedics, Inc.为申报人的其他记录

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