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FDA 510(k)

CAPENERGY - C100, C200, C300, C400, C50

K-Number: K191202 · 2020-02-11

ApplicantCapenergy Medical S.L.
Decision Date2020-02-11
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CAPENERGY - C100, C200, C300, C400, C50 is the device name listed in this FDA 510(k) record. The listed applicant is Capenergy Medical S.L.. It received FDA 510(k) clearance on 2020-02-11 under 510(k) number K191202. 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 CAPENERGY - C100, C200, C300, C400, C50?

CAPENERGY - C100, C200, C300, C400, C50 is a medical device that received FDA 510(k) clearance on 2020-02-11. The listed applicant is Capenergy Medical S.L.. The 510(k) number is K191202.

When did CAPENERGY - C100, C200, C300, C400, C50 receive FDA 510(k) clearance?

CAPENERGY - C100, C200, C300, C400, C50 received FDA 510(k) clearance on 2020-02-11, under 510(k) number K191202.

Who is the listed applicant for CAPENERGY - C100, C200, C300, C400, C50?

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

What is the FDA product code for CAPENERGY - C100, C200, C300, C400, C50?

The FDA product code for CAPENERGY - C100, C200, C300, C400, C50 is PBX.

Other records listing Capenergy Medical S.L. 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.

K253480Capenergy C Equipments RF C200 and C400 DrakarianK222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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