SonoTAP and SonoTAP II
K-Number: K243525 · 2025-03-24
ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2025-03-24
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
SonoTAP and SonoTAP II is a medical device manufactured by PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2025-03-24 under approval number K243525. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SonoTAP and SonoTAP II?
SonoTAP and SonoTAP II is a medical device that received FDA 510(k) clearance on 2025-03-24. It is manufactured by PAJUNK GmbH Medizintechnologie. The 510(k) number is K243525.
When was SonoTAP and SonoTAP II approved by the FDA?
SonoTAP and SonoTAP II received FDA 510(k) clearance on 2025-03-24, under approval number K243525.
What company makes SonoTAP and SonoTAP II?
SonoTAP and SonoTAP II is manufactured by PAJUNK GmbH Medizintechnologie.
What is the FDA product code for SonoTAP and SonoTAP II?
The FDA product code for SonoTAP and SonoTAP II is BSP.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.