K253463
- 510(k) number
- K253463
- Device name
- ILR ECG Analyzer (IM007)
- Applicant
- Implicity, Inc. MA · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2026-07-02
- Date received
- 2025-10-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253463.pdf
Official FDA record: K253463
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.