K233521
- 510(k) number
- K233521
- Device name
- QT ECG (QTERD100)
- Applicant
- QT Medical, Inc. CA · US
- Product code
- DXH — Transmitters And Receivers, Electrocardiograph, Tele
- Decision date
- 2023-12-06
- Date received
- 2023-11-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K233521.pdf
Official FDA record: K233521
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.