FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
K Number: K871268
·
Decision Jun 10, 1987
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
86
Applicant Total
3
Review Days
71
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
- RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
- K Number
- K871268
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- G. Rodenstock Instrumente GmbH
- Date Received
- March 31, 1987
- Decision Date
- June 10, 1987
- Product Code
- HLI
- 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 |
|---|---|---|---|
| HLI | Ophthalmoscope, Ac-Powered | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HLI), ordered by most recent decision date.
RTVue XR OCT Avanti with AngioVue Software
FDA 510(k)
FDA Class 2
·Ophthalmic
EnFocus 2300, EnFocus 4400
FDA 510(k)
FDA Class 2
·Ophthalmic
OCT-Camera
FDA 510(k)
FDA Class 2
·Ophthalmic
PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE
FDA 510(k)
FDA Class 2
·Ophthalmic
CENTERVUE MACULAR INTEGRITY ASSESSMENT
FDA 510(k)
FDA Class 2
·Ophthalmic
AMICO DH-W35 OPHTHALMOSCOPE SERIES
FDA 510(k)
FDA Class 2
·Ophthalmic