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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K220527
Device Name PADnet Xpress
Applicant
Collaborative Care Diagnostics, LLC, D.B.A. Biomedix
860 Blue Gentian Rd.
Suite 180
Eagan,  MN  55121
Applicant Contact James Hartnett
Correspondent
Collaborative Care Diagnostics, LLC, D.B.A. Biomedix
860 Blue Gentian Rd.
Suite 180
Eagan,  MN  55121
Correspondent Contact James Hartnett
Regulation Number870.2780
Classification Product Code
JOM  
Date Received02/24/2022
Decision Date 10/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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