Perin Health System (PHD80060-2)

510(k)K252984CardiovascularDRG

Perin Health Devices, LLC is listed for Perin Health System (PHD80060-2) (K252984). The FDA list gives January 22, 2026 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is DRG. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252984

Official FDA database record

Date of final decision: January 22, 2026
Company on the FDA list: Perin Health Devices, LLC
Lead panel: Cardiovascular
Primary product code: DRG
openFDA device name for the code: Transmitters And Receivers, Physiological Signal, Radiofrequency
Device class: 2
Regulation number: 870.2910
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary