FDA 510(k)
FDA class 2
Substantially Equivalent
🇲🇽 Mexico
MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System
K Number: K193637
·
Decision Jan 28, 2020
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
4
Review Days
32
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Basic Information
- Device Name
- MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System
- K Number
- K193637
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.
- Date Received
- December 27, 2019
- Decision Date
- January 28, 2020
- Product Code
- KPR
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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