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FDA 510(k)

HPM-6000

K-Number: K160992 · 2016-10-21

ApplicantBTL Industries, Inc.
Decision Date2016-10-21
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HPM-6000 is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2016-10-21 under approval number K160992. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HPM-6000?

HPM-6000 is a medical device that received FDA 510(k) clearance on 2016-10-21. It is manufactured by BTL Industries, Inc.. The 510(k) number is K160992.

When was HPM-6000 approved by the FDA?

HPM-6000 received FDA 510(k) clearance on 2016-10-21, under approval number K160992.

What company makes HPM-6000?

HPM-6000 is manufactured by BTL Industries, Inc..

What is the FDA product code for HPM-6000?

The FDA product code for HPM-6000 is IPF.

Other Devices by BTL Industries, Inc.

K162010HPM-6000U K161551TR-100 K152731XP1100 RF K163165AM-100 K163176Exilis XP II K180359BTL-FR2000

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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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