K233160
- 510(k) number
- K233160
- Device name
- NeuTrace EP Mapping System v.2.1
- Applicant
- Anumana, Inc. MA · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2023-11-25
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233160.pdf
Official FDA record: K233160
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.