K242800
- 510(k) number
- K242800
- Device name
- The 5000 Compact Series Ultrasound Systems
- Applicant
- Philips Ultrasound, LLC WA · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2024-11-15
- Date received
- 2024-09-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K242800.pdf
Official FDA record: K242800
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.