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FDA 510(k)

Mini Ridge Filter and auxiliary functions for PROBEAT-V

K-Number: K181676 · 2018-08-15

ApplicantHitachi Ltd. Healthcare Hitachi Works
Decision Date2018-08-15
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Mini Ridge Filter and auxiliary functions for PROBEAT-V is a medical device manufactured by Hitachi Ltd. Healthcare Hitachi Works. It received FDA 510(k) clearance on 2018-08-15 under approval number K181676. 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 Mini Ridge Filter and auxiliary functions for PROBEAT-V?

Mini Ridge Filter and auxiliary functions for PROBEAT-V is a medical device that received FDA 510(k) clearance on 2018-08-15. It is manufactured by Hitachi Ltd. Healthcare Hitachi Works. The 510(k) number is K181676.

When was Mini Ridge Filter and auxiliary functions for PROBEAT-V approved by the FDA?

Mini Ridge Filter and auxiliary functions for PROBEAT-V received FDA 510(k) clearance on 2018-08-15, under approval number K181676.

What company makes Mini Ridge Filter and auxiliary functions for PROBEAT-V?

Mini Ridge Filter and auxiliary functions for PROBEAT-V is manufactured by Hitachi Ltd. Healthcare Hitachi Works.

What is the FDA product code for Mini Ridge Filter and auxiliary functions for PROBEAT-V?

The FDA product code for Mini Ridge Filter and auxiliary functions for PROBEAT-V is LHN.

Related Devices (Code: 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.

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