K241781
- 510(k) number
- K241781
- Device name
- Solo Pace Control
- Applicant
- Solo Pace, Inc. CA · US
- Product code
- DTE — Pulse-Generator, Pacemaker, External
- Decision date
- 2025-01-10
- Date received
- 2024-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.7 MB · U.S. public domain
Also available from FDA: K241781.pdf
Official FDA record: K241781
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.