FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LR 5200 LASER FILM RECORDER
K Number: K964414
·
Decision Jan 27, 1997
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
120
Applicant Total
3
Review Days
83
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Basic Information
- Device Name
- LR 5200 LASER FILM RECORDER
- K Number
- K964414
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2040
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Corp., Agfa Div.
- Date Received
- November 5, 1996
- Decision Date
- January 27, 1997
- Product Code
- LMC
- 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 |
|---|---|---|---|
| LMC | Camera, Multi Format, Radiological | FDA class 2 | Radiology |
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