HPM-6000UF
K-Number: K181497 · 2018-11-14
ApplicantBTL Industries, Inc.
Decision Date2018-11-14
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
HPM-6000UF is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2018-11-14 under approval number K181497. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HPM-6000UF?
HPM-6000UF is a medical device that received FDA 510(k) clearance on 2018-11-14. It is manufactured by BTL Industries, Inc.. The 510(k) number is K181497.
When was HPM-6000UF approved by the FDA?
HPM-6000UF received FDA 510(k) clearance on 2018-11-14, under approval number K181497.
What company makes HPM-6000UF?
HPM-6000UF is manufactured by BTL Industries, Inc..
What is the FDA product code for HPM-6000UF?
The FDA product code for HPM-6000UF is KPI.
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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.