FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
HIGH SPEED EMG MODULE
K Number: K031930
·
Decision Mar 3, 2004
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
138
Applicant Total
7
Review Days
254
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Basic Information
- Device Name
- HIGH SPEED EMG MODULE
- K Number
- K031930
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Measurement Systems B.V.
- Date Received
- June 23, 2003
- Decision Date
- March 3, 2004
- Product Code
- GWF
- 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 |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | FDA class 2 | Neurology |
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Other Clearances by Medical Measurement Systems B.V.
| K Number | Device Name | ||
|---|---|---|---|
| K121014 | SOLAR GI | Aug 1, 2012 | Substantially Equivalent |
| K071094 | MODIFICATION TO SOLAR GI | Aug 13, 2007 | Substantially Equivalent |
| K060166 | OHMEGA | Apr 21, 2006 | Substantially Equivalent |
| K052338 | SOLAR GI | Dec 15, 2005 | Substantially Equivalent |
| K050993 | MMS VIDEO OPTION | May 26, 2005 | Substantially Equivalent |
| K031084 | SOLAR GI SYSTEM | Mar 19, 2004 | Substantially Equivalent |