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510(k) K220527

PADnet Xpress by Collaborative Care Diagnostics, LLC, D.B.A. Biomedix — Product Code JOM

K220527 is an FDA 510(k) premarket notification submitted by Collaborative Care Diagnostics, LLC, D.B.A. Biomedix for the device "PADnet Xpress". The FDA issued a decision of Substantially Equivalent on October 20, 2022. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2022
Date Received
February 24, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class
Class II
Regulation Number
870.2780
Review Panel
CV
Submission Type

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FDA data resources