Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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.

Frequently Asked Questions

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.

Related Devices (Code: JOM)

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.

K213730MESI mTABLET TBI diagnostic system, MESI mTABLET TBIMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.K200567ASI Plethysmogrpah AnalyzerArterial 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

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.

↑