TheraVision Ultrasound Ablation System and ACOUSTx Applicators— 510(k) K150019
Substantially EquivalentAcoustic Medsystems, Inc.
FDA 510(k) clearance K150019 for TheraVision Ultrasound Ablation System and ACOUSTx Applicators, Substantially Equivalent on 2016-01-13. Applicant: Acoustic Medsystems, Inc.. Device class: 2.
Clearance details
- Applicant
- Acoustic Medsystems, Inc.
- Product code
- Code NTB
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Savoy, IL, US
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