PROBEAT-V and accessories
K-Number: K153614 · 2016-04-21
ApplicantHitachi, Ltd., Health Care Company
Decision Date2016-04-21
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
PROBEAT-V and accessories is a medical device manufactured by Hitachi, Ltd., Health Care Company. It received FDA 510(k) clearance on 2016-04-21 under approval number K153614. 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-V and accessories?
PROBEAT-V and accessories is a medical device that received FDA 510(k) clearance on 2016-04-21. It is manufactured by Hitachi, Ltd., Health Care Company. The 510(k) number is K153614.
When was PROBEAT-V and accessories approved by the FDA?
PROBEAT-V and accessories received FDA 510(k) clearance on 2016-04-21, under approval number K153614.
What company makes PROBEAT-V and accessories?
PROBEAT-V and accessories is manufactured by Hitachi, Ltd., Health Care Company.
What is the FDA product code for PROBEAT-V and accessories?
The FDA product code for PROBEAT-V and accessories 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.