FDA 510(k)

SIDDHARTH-II; IMPACT

K号: K210894 · 2021-09-28

申请人Panacea Medical Technologies Pvt. , Ltd.

决定日期2021-09-28

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

SIDDHARTH-II; IMPACT is the device name listed in this FDA 510(k) record. The listed applicant is Panacea Medical Technologies Pvt. , Ltd.. It received FDA 510(k) clearance on 2021-09-28 under 510(k) number K210894. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SIDDHARTH-II; IMPACT?

SIDDHARTH-II; IMPACT is a medical device that received FDA 510(k) clearance on 2021-09-28. The listed applicant is Panacea Medical Technologies Pvt. , Ltd.. The 510(k) number is K210894.

When did SIDDHARTH-II; IMPACT receive FDA 510(k) clearance?

SIDDHARTH-II; IMPACT received FDA 510(k) clearance on 2021-09-28, under 510(k) number K210894.

Who is the listed applicant for SIDDHARTH-II; IMPACT?

The FDA 510(k) record lists Panacea Medical Technologies Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIDDHARTH-II; IMPACT?

The FDA product code for SIDDHARTH-II; IMPACT is IYE.

列明Panacea Medical Technologies Pvt. , Ltd.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。

K222762SIDDHARTH-II;IMPACT

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