FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL
K Number: K082627
·
Decision Nov 7, 2008
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
223
Applicant Total
13
Review Days
59
Basic Information
- Device Name
- MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL
- K Number
- K082627
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MINXRAY, INC.
- Date Received
- September 9, 2008
- Decision Date
- November 7, 2008
- Product Code
- IZL
- 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 |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | FDA class 2 | Radiology |
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|---|---|---|---|
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