510(k) DEN230082
- Device
- Stone Clear (SC-LP9-01)
- Applicant
- Sonomotion, Inc.
- 510(k) number
- DEN230082
- Product code
- QNA
- Decision
- Unknown (DENG)
- Decision date
- 2024-10-30
- Date received
- 2023-12-07
- Regulation
- 876.4690
- Classification name
- Ultrasonic Urinary Stone Propulsion Device
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Oren Levy
- Address
- 1600 W. Hillsdale Blvd., Suite 105 San Mateo CA US 94402 94402
Source Documents
510(k) summary PDF not indicated by FDA