Pro-Tx Endorectal Balloon (PROT-25)— 510(k) K223249

Substantially Equivalent

Dxtx Medical, Inc.

FDA 510(k) clearance K223249 for Pro-Tx Endorectal Balloon (PROT-25), Substantially Equivalent on 2023-02-10. Applicant: Dxtx Medical, Inc..

Clearance details

Applicant: Dxtx Medical, Inc.
Product code: Code PCT
Advisory panel: Radiology
Date received: 2022-09-12
Decision date: 2023-02-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Pittsburgh, PA, US

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