PROBEAT-CR
K-Number: K191801 · 2019-09-13
ApplicantHitachi , Ltd.
Decision Date2019-09-13
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
PROBEAT-CR is a medical device manufactured by Hitachi , Ltd.. It received FDA 510(k) clearance on 2019-09-13 under approval number K191801. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PROBEAT-CR?
PROBEAT-CR is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Hitachi , Ltd.. The 510(k) number is K191801.
When was PROBEAT-CR approved by the FDA?
PROBEAT-CR received FDA 510(k) clearance on 2019-09-13, under approval number K191801.
What company makes PROBEAT-CR?
PROBEAT-CR is manufactured by Hitachi , Ltd..
What is the FDA product code for PROBEAT-CR?
The FDA product code for PROBEAT-CR is LHN.
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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.