K233354
- 510(k) number
- K233354
- Device name
- WVSM Pro (Series) (500-0030-XX)
- Applicant
- Athena Gtx, Inc. IA · US
- Product code
- MWI — Monitor, Physiological, Patient (Without Arrhythmia
- Decision date
- 2024-06-26
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233354.pdf
Official FDA record: K233354
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.