K242487
- 510(k) number
- K242487
- Device name
- Laminar P1 (LDH-HW-001)
- Applicant
- Laminar Digital Health, Inc. CA · US
- Product code
- JAF — Monitor, Ultrasonic, Nonfetal
- Decision date
- 2024-12-13
- Date received
- 2024-08-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K242487.pdf
Official FDA record: K242487
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.