K242997
- 510(k) number
- K242997
- Device name
- MY01 Continuous Compartmental Pressure Monitor
- Applicant
- MY01, Inc. CA
- Product code
- LXC — Monitor, Pressure, Intracompartmental
- Decision date
- 2025-03-13
- Date received
- 2024-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K242997.pdf
Official FDA record: K242997
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.