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FDA 510(k)

eMVFit (MVF-10M)

K-Number: K240991 · 2024-10-09

ApplicantWeero Co., Ltd.
Decision Date2024-10-09
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

eMVFit (MVF-10M) is a medical device manufactured by Weero Co., Ltd.. It received FDA 510(k) clearance on 2024-10-09 under approval number K240991. 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 eMVFit (MVF-10M)?

eMVFit (MVF-10M) is a medical device that received FDA 510(k) clearance on 2024-10-09. It is manufactured by Weero Co., Ltd.. The 510(k) number is K240991.

When was eMVFit (MVF-10M) approved by the FDA?

eMVFit (MVF-10M) received FDA 510(k) clearance on 2024-10-09, under approval number K240991.

What company makes eMVFit (MVF-10M)?

eMVFit (MVF-10M) is manufactured by Weero Co., Ltd..

What is the FDA product code for eMVFit (MVF-10M)?

The FDA product code for eMVFit (MVF-10M) is PBX.

Other Devices by Weero Co., Ltd.

K240992eMVFit (MVF-10M) K241433EVE Synergy (EVE-20M) K253261Apollo Quattro (APQ-10M)

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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