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FDA 510(k)

ElastiMed SACS

K-Number: K232300 · 2023-12-22

ApplicantElastimed , Ltd.
Decision Date2023-12-22
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ElastiMed SACS is the device name listed in this FDA 510(k) record. The listed applicant is Elastimed , Ltd.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K232300. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ElastiMed SACS?

ElastiMed SACS is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Elastimed , Ltd.. The 510(k) number is K232300.

When did ElastiMed SACS receive FDA 510(k) clearance?

ElastiMed SACS received FDA 510(k) clearance on 2023-12-22, under 510(k) number K232300.

Who is the listed applicant for ElastiMed SACS?

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

What is the FDA product code for ElastiMed SACS?

The FDA product code for ElastiMed SACS is JOW.

Other records listing Elastimed , 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.

K243177SACS PRO

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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