FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
MDPC-8127
K Number: K203364
·
Decision Apr 15, 2021
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
18
Applicant Total
60
Review Days
150
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Basic Information
- Device Name
- MDPC-8127
- K Number
- K203364
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.3700
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Barco N.V.
- Date Received
- November 16, 2020
- Decision Date
- April 15, 2021
- Product Code
- PSY
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| PSY | Whole Slide Imaging System | FDA class 2 | Pathology |
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