510(k) K254074

Device
TruPress
Applicant
Procerus Enterprises
510(k) number
K254074
Product code
DRS
Decision
Substantially Equivalent (SESE)
Decision date
2026-09-10
Date received
2025-12-18
Regulation
870.2850
Classification name
Transducer, Blood-Pressure, Extravascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jordan Cox
Address
2505 E. 3300 S Suite 202 Salt Lake City UT US 84124 84124

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DRS#

510(k), Device, Applicant table
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