K252984
- 510(k) number
- K252984
- Device name
- Perin Health System (PHD80060-2)
- Applicant
- Perin Health Devices, LLC OK · US
- Product code
- DRG — Transmitters And Receivers, Physiological Signal, Ra
- Decision date
- 2026-01-22
- Date received
- 2025-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252984.pdf
Official FDA record: K252984
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.