FDA 510(k)

Diacare 7000

K-Number: K211207 · 2022-06-06

ApplicantGlobus Sport and Health Technologies, LLC

Decision Date2022-06-06

Product CodePBX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Diacare 7000 is the device name listed in this FDA 510(k) record. The listed applicant is Globus Sport and Health Technologies, LLC. It received FDA 510(k) clearance on 2022-06-06 under 510(k) number K211207. 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 Diacare 7000?

Diacare 7000 is a medical device that received FDA 510(k) clearance on 2022-06-06. The listed applicant is Globus Sport and Health Technologies, LLC. The 510(k) number is K211207.

When did Diacare 7000 receive FDA 510(k) clearance?

Diacare 7000 received FDA 510(k) clearance on 2022-06-06, under 510(k) number K211207.

Who is the listed applicant for Diacare 7000?

The FDA 510(k) record lists Globus Sport and Health Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diacare 7000?

The FDA product code for Diacare 7000 is PBX.

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.