K251670
- 510(k) number
- K251670
- Device name
- MAC 7 Resting ECG Analysis System
- Applicant
- Ge Medical Systems Information Technologies, Inc. WI · US
- Product code
- DPS — Electrocardiograph
- Decision date
- 2026-01-26
- Date received
- 2025-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K251670.pdf
Official FDA record: K251670
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.