McLaren Proton Therapy System— 510(k) K160063
Substantially EquivalentMclaren Health Care Corporation
FDA 510(k) clearance K160063 for McLaren Proton Therapy System, Substantially Equivalent on 2016-02-25. Applicant: Mclaren Health Care Corporation. Device class: 2.
Clearance details
- Applicant
- Mclaren Health Care Corporation
- Product code
- Code LHN
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Flint, MI, US
Recent devices under product code LHN
view allData sourced from openFDA. This site is unofficial and independent of the FDA.