PADnet Xpress— 510(k) K220527

Name: FDA 510(k) clearance K220527
Creator: U.S. Food and Drug Administration
Published: 2022-10-20

Substantially Equivalent

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

FDA 510(k) clearance K220527 for PADnet Xpress, Substantially Equivalent on 2022-10-20. Applicant: Collaborative Care Diagnostics, LLC, D.B.A. Biomedix. Device class: 2.

Clearance details

Applicant: Collaborative Care Diagnostics, LLC, D.B.A. Biomedix
Product code: Code JOM
Device class: Class 2
Regulation: 21 CFR 870.2780
Advisory panel: Cardiovascular
Date received: 2022-02-24
Decision date: 2022-10-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Eagan, MN, US

Download summary PDF View on FDA.gov ↗

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