FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
VECTORSONIC, MODEL VU-270
K Number: K030880
·
Decision Apr 18, 2003
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
54
Applicant Total
17
Review Days
29
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Basic Information
- Device Name
- VECTORSONIC, MODEL VU-270
- K Number
- K030880
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.5860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Metron Medical Australia, Pty, Ltd.
- Date Received
- March 20, 2003
- Decision Date
- April 18, 2003
- Product Code
- IMG
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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Other Clearances by Metron Medical Australia, Pty, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K132137 | MULTISTIM | Sep 12, 2013 | Substantially Equivalent |
| K124010 | ACCUSONIC ADVANTAGE | Aug 23, 2013 | Substantially Equivalent |
| K120171 | ACCUSONIC ADVANTAGE | May 4, 2012 | Substantially Equivalent |
| K030878 | ACCOUSONIC, MODEL AS-270 | Mar 28, 2003 | Substantially Equivalent |
| K030648 | VECTORSURGE 5 MODEL 470 | Mar 28, 2003 | Substantially Equivalent |
| K030410 | ACCOUSONIC PLUS, MODEL AP-170 | Feb 20, 2003 | Substantially Equivalent |
| K020119 | VECTORSONIC, MODEL VU-200 | Jul 22, 2002 | Substantially Equivalent |
| K011955 | MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 | Jul 16, 2001 | Substantially Equivalent |
| K001897 | MULTI-STIM, MODEL MS-100 | Jun 12, 2001 | Substantially Equivalent |
| K002058 | VECTORSURGE 5, MODEL VS-500 | May 29, 2001 | Substantially Equivalent |