FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
A O MICROSCOPE VIDEO SYSTEM
K Number: K821865
·
Decision Jul 14, 1982
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
8
Applicant Total
50
Review Days
20
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Basic Information
- Device Name
- A O MICROSCOPE VIDEO SYSTEM
- K Number
- K821865
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3600
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Warner-Lambert Co.
- Date Received
- June 24, 1982
- Decision Date
- July 14, 1982
- Product Code
- IBJ
- 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 |
|---|---|---|---|
| IBJ | Light, Microscope | FDA class 1 | Pathology |
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