SofWave System— 510(k) K241685
Substantially EquivalentSofwave Medical, Ltd.
FDA 510(k) clearance K241685 for SofWave System, Substantially Equivalent on 2024-08-07. Applicant: Sofwave Medical, Ltd.. Device class: 2.
Clearance details
- Applicant
- Sofwave Medical, Ltd.
- Product code
- Code NGX
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yokneam Iiit, IL
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