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FDA 510(k)

SACS PRO

K-Number: K243177 · 2024-12-23

ApplicantElastimed , Ltd.
Decision Date2024-12-23
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SACS PRO is a medical device manufactured by Elastimed , Ltd.. It received FDA 510(k) clearance on 2024-12-23 under approval number K243177. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SACS PRO?

SACS PRO is a medical device that received FDA 510(k) clearance on 2024-12-23. It is manufactured by Elastimed , Ltd.. The 510(k) number is K243177.

When was SACS PRO approved by the FDA?

SACS PRO received FDA 510(k) clearance on 2024-12-23, under approval number K243177.

What company makes SACS PRO?

SACS PRO is manufactured by Elastimed , Ltd..

What is the FDA product code for SACS PRO?

The FDA product code for SACS PRO is IRP.

Other Devices by Elastimed , Ltd.

K232300ElastiMed SACS

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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.

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