FDA 510(k)

PADnet Xpress

K-Nummer: K220527 · 2022-10-20

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

Entscheidungsdatum2022-10-20

ProduktcodeJOM

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Offizielle Quelle

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