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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 a medical device manufactured by Globus Sport and Health Technologies, LLC. It received FDA 510(k) clearance on 2022-06-06 under approval 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. It is manufactured by Globus Sport and Health Technologies, LLC. The 510(k) number is K211207.

When was Diacare 7000 approved by the FDA?

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

What company makes Diacare 7000?

Diacare 7000 is manufactured by Globus Sport and Health Technologies, LLC.

What is the FDA product code for Diacare 7000?

The FDA product code for Diacare 7000 is PBX.

Related Devices (Code: PBX)

K162512truSculptCutera, Inc. K161458Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep CareIndiba USA, Inc. K161551TR-100BTL Industries, Inc. K161043Profound SystemSyneron Candela Corporation K160329InMode System MiniFX HandpieceInmode MD , Ltd. K161199EndyMed Contour HandpieceEndymed Medical, 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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