FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIEWSCAN
K Number: K863994
·
Decision Oct 31, 1986
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
1
Applicant Total
4
Review Days
17
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Basic Information
- Device Name
- VIEWSCAN
- K Number
- K863994
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5910
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Sensory Aids Corp.
- Date Received
- October 14, 1986
- Decision Date
- October 31, 1986
- Product Code
- HOT
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HOT | Aid, Vision Image Intensification | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HOT), ordered by most recent decision date.
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