FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC
K Number: K063289
·
Decision Nov 16, 2006
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
4
Review Days
15
Basic Information
- Device Name
- 2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC
- K Number
- K063289
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CHI LIN TECHNOLOGY CO., LTD.
- Date Received
- November 1, 2006
- Decision Date
- November 16, 2006
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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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Other Clearances by CHI LIN TECHNOLOGY CO., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K063269 | 5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC | May 23, 2007 | Substantially Equivalent |
| K063579 | 2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC | Dec 14, 2006 | Substantially Equivalent |
| K063266 | 3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC | Nov 9, 2006 | Substantially Equivalent |