FDA 510(k)

PADnet Xpress

Номер K: K220527 · 2022-10-20

ЗаявительCollaborative Care Diagnostics, LLC, D.B.A. Biomedix

Дата решения2022-10-20

Код продуктаJOM

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

PADnet Xpress is the device name listed in this FDA 510(k) record. The listed applicant is Collaborative Care Diagnostics, LLC, D.B.A. Biomedix. It received FDA 510(k) clearance on 2022-10-20 under 510(k) number K220527. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the PADnet Xpress?

PADnet Xpress is a medical device that received FDA 510(k) clearance on 2022-10-20. The listed applicant is Collaborative Care Diagnostics, LLC, D.B.A. Biomedix. The 510(k) number is K220527.

When did PADnet Xpress receive FDA 510(k) clearance?

PADnet Xpress received FDA 510(k) clearance on 2022-10-20, under 510(k) number K220527.

Who is the listed applicant for PADnet Xpress?

The FDA 510(k) record lists Collaborative Care Diagnostics, LLC, D.B.A. Biomedix as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PADnet Xpress?

The FDA product code for PADnet Xpress is JOM.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: JOM)

K213730MESI mTABLET TBI diagnostic system, MESI mTABLET TBIMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.K200567ASI Анализатор плетизмографииArterial Stiffness, Inc.K201046Automated ankle brachial pressure index measuring device, MESI mTABLET systemMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.K191266VitalScan ANSMedeia, Inc.K172655Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.K173696TBL-ABI SystemLd Technology, LLC

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