K231870
- 510(k) number
- K231870
- Device name
- CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
- Applicant
- Ge Medical Systems Information Technologies, Inc. WI · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2023-12-13
- Date received
- 2023-06-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K231870.pdf
Official FDA record: K231870
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.