FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
MMS VIDEO OPTION
K Number: K050993
·
Decision May 26, 2005
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
7
Review Days
37
Basic Information
- Device Name
- MMS VIDEO OPTION
- K Number
- K050993
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- MEDICAL MEASUREMENT SYSTEMS,B.V.
- Date Received
- April 19, 2005
- Decision Date
- May 26, 2005
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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|---|---|---|---|
| K121014 | SOLAR GI | Aug 1, 2012 | Substantially Equivalent |
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| K031930 | HIGH SPEED EMG MODULE | Mar 3, 2004 | Substantially Equivalent |