HPM-6000U
K-Number: K162010 · 2016-12-13
ApplicantBTL Industries, Inc.
Decision Date2016-12-13
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
HPM-6000U is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2016-12-13 under approval number K162010. 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-6000U?
HPM-6000U is a medical device that received FDA 510(k) clearance on 2016-12-13. It is manufactured by BTL Industries, Inc.. The 510(k) number is K162010.
When was HPM-6000U approved by the FDA?
HPM-6000U received FDA 510(k) clearance on 2016-12-13, under approval number K162010.
What company makes HPM-6000U?
HPM-6000U is manufactured by BTL Industries, Inc..
What is the FDA product code for HPM-6000U?
The FDA product code for HPM-6000U is KPI.
Other Devices by BTL Industries, Inc.
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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.