K220396
- 510(k) number
- K220396
- Device name
- EasyStat 300
- Applicant
- Medica Corporation MA · US
- Product code
- CEM — Electrode, Ion Specific, Potassium
- Decision date
- 2023-09-26
- Date received
- 2022-02-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K220396.pdf
Official FDA record: K220396
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.