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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 the device name listed in this FDA 510(k) record. The listed applicant is BTL Industries, Inc.. It received FDA 510(k) clearance on 2016-10-21 under 510(k) 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. The listed applicant is BTL Industries, Inc.. The 510(k) number is K160992.

When did HPM-6000 receive FDA 510(k) clearance?

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

Who is the listed applicant for HPM-6000?

The FDA 510(k) record lists BTL Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HPM-6000?

The FDA product code for HPM-6000 is IPF.

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Other records listing BTL Industries, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252963BTL-899TTK253750BTL-785NEHK252561BTL-754FFK250309BTL-199K243290BTL-785MJK241516BTL-398

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Related Devices (Code: IPF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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