FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VTS REPORTER OR VTS LINK
K Number: K863993
·
Decision Oct 31, 1986
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
4
Review Days
17
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Basic Information
- Device Name
- VTS REPORTER OR VTS LINK
- K Number
- K863993
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5900
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Sensory Aids Corp.
- Date Received
- October 14, 1986
- Decision Date
- October 31, 1986
- Product Code
- HPF
- 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 |
|---|---|---|---|
| HPF | Aid, Vision, Electronic, Ac-Powered | FDA class 1 | Ophthalmic |