FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VKG 1000, VIDEO KERATOMETER
K Number: K883471
·
Decision Nov 8, 1988
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
2
Applicant Total
3
Review Days
84
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VKG 1000, VIDEO KERATOMETER
- K Number
- K883471
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1880
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Technitex, Inc.
- Date Received
- August 16, 1988
- Decision Date
- November 8, 1988
- Product Code
- HLP
- 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 |
|---|---|---|---|
| HLP | Target, Fusion And Stereoscopic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HLP), ordered by most recent decision date.
THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT.
FDA 510(k)
FDA Class 1
·Ophthalmic
WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT
FDA 510(k)
FDA Class 1
·Ophthalmic