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FDA 510(k)

SIDDHARTH-II; IMPACT

K-Number: K210894 · 2021-09-28

ApplicantPanacea Medical Technologies Pvt. , Ltd.
Decision Date2021-09-28
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Panacea Medical Technologies Pvt. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222762SIDDHARTH-II;IMPACT

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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