ElastiMed SACS— 510(k) K232300

Substantially Equivalent

Elastimed , Ltd.

FDA 510(k) clearance K232300 for ElastiMed SACS, Substantially Equivalent on 2023-12-22. Applicant: Elastimed , Ltd.. Device class: 2.

Clearance details

Applicant: Elastimed , Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2023-08-01
Decision date: 2023-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam Ilit, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.