FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
MULTI-STIM, MODEL MS-100
K Number: K001897
·
Decision Jun 12, 2001
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
17
Review Days
356
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Basic Information
- Device Name
- MULTI-STIM, MODEL MS-100
- K Number
- K001897
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Metron Medical Australia, Pty, Ltd.
- Date Received
- June 21, 2000
- Decision Date
- June 12, 2001
- Product Code
- GZJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
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| K030880 | VECTORSONIC, MODEL VU-270 | Apr 18, 2003 | 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 |
| K002058 | VECTORSURGE 5, MODEL VS-500 | May 29, 2001 | Substantially Equivalent |