FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PATHFINDER
K Number: K910601
·
Decision May 14, 1991
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
6
Applicant Total
3
Review Days
90
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
- PATHFINDER
- K Number
- K910601
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5900
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Nurion Industries
- Date Received
- February 13, 1991
- Decision Date
- May 14, 1991
- Product Code
- HPG
- 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 |
|---|---|---|---|
| HPG | Aid, Vision, Electronic, Battery-Powered | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HPG), ordered by most recent decision date.
LOW VISION ENHANCEMENT SYSTEM (LVES)
FDA 510(k)
FDA Class 1
·Ophthalmic
LASER CANE
FDA 510(k)
FDA Class 1
·Ophthalmic
POLARON
FDA 510(k)
FDA Class 1
·Ophthalmic
SENSORY 6
FDA 510(k)
FDA Class 1
·Ophthalmic
ALES
FDA 510(k)
FDA Class 1
·Ophthalmic
F4912 NIGHT VISION AID
FDA 510(k)
FDA Class 1
·Ophthalmic