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FDA 510(k)

HeraBEAT™ US

K-Number: K191110 · 2019-11-14

ApplicantHeramed, Ltd.
Decision Date2019-11-14
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HeraBEAT™ US is the device name listed in this FDA 510(k) record. The listed applicant is Heramed, Ltd.. It received FDA 510(k) clearance on 2019-11-14 under 510(k) number K191110. The device is classified under product code KNG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HeraBEAT™ US?

HeraBEAT™ US is a medical device that received FDA 510(k) clearance on 2019-11-14. The listed applicant is Heramed, Ltd.. The 510(k) number is K191110.

When did HeraBEAT™ US receive FDA 510(k) clearance?

HeraBEAT™ US received FDA 510(k) clearance on 2019-11-14, under 510(k) number K191110.

Who is the listed applicant for HeraBEAT™ US?

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

What is the FDA product code for HeraBEAT™ US?

The FDA product code for HeraBEAT™ US is KNG.

Related Devices (Code: KNG)

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.

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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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