SIDDHARTH-II; IMPACT
K-Number: K210894 · 2021-09-28
Decision Date2021-09-28
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SIDDHARTH-II; IMPACT is a medical device manufactured by Panacea Medical Technologies Pvt. , Ltd.. It received FDA 510(k) clearance on 2021-09-28 under approval 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. It is manufactured by Panacea Medical Technologies Pvt. , Ltd.. The 510(k) number is K210894.
When was SIDDHARTH-II; IMPACT approved by the FDA?
SIDDHARTH-II; IMPACT received FDA 510(k) clearance on 2021-09-28, under approval number K210894.
What company makes SIDDHARTH-II; IMPACT?
SIDDHARTH-II; IMPACT is manufactured by Panacea Medical Technologies Pvt. , Ltd..
What is the FDA product code for SIDDHARTH-II; IMPACT?
The FDA product code for SIDDHARTH-II; IMPACT is IYE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.