AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM— 510(k) K131096
Substantially EquivalentArobella Medical, LLC
FDA 510(k) clearance K131096 for AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM, Substantially Equivalent on 2014-05-16. Applicant: Arobella Medical, LLC.
Clearance details
- Applicant
- Arobella Medical, LLC
- Product code
- Code NRB
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minnetonka, MN, US
Adverse events under product code NRB
product code NRB- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.