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Data / Medical devices / United States / Interson Corp.

Interson Corp.: FDA-registered device maker in Pleasanton, CA, United States, 3 510(k) clearances

Interson Corp. is registered with the FDA (registration 2939830) in Pleasanton, CA, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 22, 2023. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
2939830
FEI number
1000124215
Address
7150 Koll Center Pkwy, Pleasanton, CA, United States, 94566
Owner or operator
Interson Corporation (9000675)
Roles
Contract manufacturer, Manufacturer
First device listed
December 14, 2007
Registered through
2027
Brand names listed
CPMX1, Interson SiMPLi Series, Interson USB Ultrasound Probe System, VPS Rhythm DLX Ultrasound Probe, VPS Rhythm DLX Ultrasound Probe, Rebuilt

Devices it lists

DeviceProduct codeClassRoleSource
Monitor, Pressure, IntracompartmentalLXCUContract manufactureraccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Contract manufacturer, Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Contract manufacturer, Manufactureraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Contract manufacturer, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 22, 2023K233734Interson USB Ultrasound SystemIYNSubstantially EquivalentInterson Corporationaccessdata.fda.gov
April 13, 2017K163443Interson USB Ultrasound SystemIYNSubstantially EquivalentInterson Corporationaccessdata.fda.gov
April 17, 2007K070907INTERSON USB ULTRASOUND PROBE SYSTEMIYOSubstantially EquivalentRegulatory Management Servicesaccessdata.fda.gov

Compare with other makers

Updated December 22, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.