K253293
- 510(k) number
- K253293
- Device name
- VitaloJAK Clinic (Model 7100)
- Applicant
- Vitalograph , Ltd. IE
- Product code
- DSH — Recorder, Magnetic Tape, Medical
- Decision date
- 2025-12-03
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K253293.pdf
Official FDA record: K253293
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.