FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
AR1000 ULTRASONIC WOUND THERAPY SYSTEM
K Number: K062544
·
Decision Jan 3, 2007
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
3
Review Days
126
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Basic Information
- Device Name
- AR1000 ULTRASONIC WOUND THERAPY SYSTEM
- K Number
- K062544
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arobella Medical, LLC
- Date Received
- August 30, 2006
- Decision Date
- January 3, 2007
- Product Code
- LFL
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
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