FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇪 Germany
POLYSCAN DIGITAL SCANNER
K Number: K944684
·
Decision May 15, 1995
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
1
Review Days
235
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Basic Information
- Device Name
- POLYSCAN DIGITAL SCANNER
- K Number
- K944684
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1300
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mse Medizintechnik GmbH & Co. KG
- Date Received
- September 22, 1994
- Decision Date
- May 15, 1995
- Product Code
- IYW
- 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 |
|---|---|---|---|
| IYW | Scanner, Rectilinear, Nuclear | FDA class 1 | Radiology |
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