HeraBEAT US— 510(k) K191110

Substantially Equivalent

Heramed, Ltd.

FDA 510(k) clearance K191110 for HeraBEAT US, Substantially Equivalent on 2019-11-14. Applicant: Heramed, Ltd.. Device class: 2.

Clearance details

Applicant: Heramed, Ltd.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2019-04-26
Decision date: 2019-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, 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.