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FDA 510(k)

BTL-703-2

K-Number: K200382 · 2021-01-06

ApplicantBtl
Decision Date2021-01-06
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BTL-703-2 is the device name listed in this FDA 510(k) record. The listed applicant is Btl. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K200382. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTL-703-2?

BTL-703-2 is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is Btl. The 510(k) number is K200382.

When did BTL-703-2 receive FDA 510(k) clearance?

BTL-703-2 received FDA 510(k) clearance on 2021-01-06, under 510(k) number K200382.

Who is the listed applicant for BTL-703-2?

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

What is the FDA product code for BTL-703-2?

The FDA product code for BTL-703-2 is NGX.

Other records listing Btl 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.

K202199BTL-899STK193201BTL-785FK192224BTL-899

Related Devices (Code: NGX)

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.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.

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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