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 a medical device manufactured by Heramed, Ltd.. It received FDA 510(k) clearance on 2019-11-14 under approval 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. It is manufactured by Heramed, Ltd.. The 510(k) number is K191110.
When was HeraBEAT US approved by the FDA?
HeraBEAT US received FDA 510(k) clearance on 2019-11-14, under approval number K191110.
What company makes HeraBEAT US?
HeraBEAT US is manufactured by Heramed, Ltd..
What is the FDA product code for HeraBEAT US?
The FDA product code for HeraBEAT US is KNG.
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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.