K233446
- 510(k) number
- K233446
- Device name
- AMC Health CareConsole
- Applicant
- Amc Health NY · US
- Product code
- MWI — Monitor, Physiological, Patient (Without Arrhythmia
- Decision date
- 2024-09-27
- Date received
- 2023-10-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K233446.pdf
Official FDA record: K233446
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.