Laminar P1 (LDH-HW-001)— 510(k) K242487
Substantially EquivalentLaminar Digital Health, Inc.
FDA 510(k) clearance K242487 for Laminar P1 (LDH-HW-001), Substantially Equivalent on 2024-12-13. Applicant: Laminar Digital Health, Inc.. Device class: 2.
Clearance details
- Applicant
- Laminar Digital Health, Inc.
- Product code
- Code JAF
- Device class
- Class 2
- Regulation
- 21 CFR 892.1540
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code JAF
view allData sourced from openFDA. This site is unofficial and independent of the FDA.