K233943
- 510(k) number
- K233943
- Device name
- Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)
- Applicant
- Medtronic, Inc. MN · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2024-03-08
- Date received
- 2023-12-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K233943.pdf
Official FDA record: K233943
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.