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FDA 510(k)

TR-100

K-Number: K161551 · 2016-09-13

ApplicantBTL Industries, Inc.
Decision Date2016-09-13
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TR-100 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 2016-09-13 under 510(k) number K161551. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TR-100?

TR-100 is a medical device that received FDA 510(k) clearance on 2016-09-13. The listed applicant is BTL Industries, Inc.. The 510(k) number is K161551.

When did TR-100 receive FDA 510(k) clearance?

TR-100 received FDA 510(k) clearance on 2016-09-13, under 510(k) number K161551.

Who is the listed applicant for TR-100?

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 TR-100?

The FDA product code for TR-100 is PBX.

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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

View all 34 devices →

Related Devices (Code: PBX)

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.

K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.K250916WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., Ltd.

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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