FDA 510(k)

PADnet Xpress

K-Number: K220527 · 2022-10-20

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

Decision Date2022-10-20

Product CodeJOM

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the PADnet Xpress?

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

When was PADnet Xpress approved by the FDA?

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

What company makes PADnet Xpress?

PADnet Xpress is manufactured by Collaborative Care Diagnostics, LLC, D.B.A. Biomedix.

What is the FDA product code for PADnet Xpress?

The FDA product code for PADnet Xpress is JOM.

Related Devices (Code: JOM)

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

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.