FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TDK MEDICAL GRADE CD-R
K Number: K971848
·
Decision Aug 15, 1997
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
54
Applicant Total
1
Review Days
88
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Basic Information
- Device Name
- TDK MEDICAL GRADE CD-R
- K Number
- K971848
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2010
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tdk Electronics Corporation of America
- Date Received
- May 19, 1997
- Decision Date
- August 15, 1997
- Product Code
- LMB
- 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 |
|---|---|---|---|
| LMB | Device, Digital Image Storage, Radiological | FDA class 1 | Radiology |
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