K233038
- 510(k) number
- K233038
- Device name
- Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
- Applicant
- Edan Instruments, Inc. CN
- Product code
- MWI — Monitor, Physiological, Patient (Without Arrhythmia
- Decision date
- 2024-03-08
- Date received
- 2023-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K233038.pdf
Official FDA record: K233038
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.