AR1000 ULTRASONIC WOUND THERAPY SYSTEM
FDA 510(k) clearance K062544 · decided 2007-01-03
Clearance details
- K-number
- K062544
- Device name
- AR1000 ULTRASONIC WOUND THERAPY SYSTEM
- Applicant
- Arobella Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2006-08-30
- Decision date
- 2007-01-03
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Carmel, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. M recall (Z-0534-2013) | Arobella Medical, LLC | 2012-12-17 |