FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GENERATED RETINAL REFLEX IMAGERY SYS
K Number: K840840
·
Decision Jul 12, 1984
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
6
Applicant Total
1
Review Days
139
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
- GENERATED RETINAL REFLEX IMAGERY SYS
- K Number
- K840840
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1780
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Electro Optical Instruments
- Date Received
- February 24, 1984
- Decision Date
- July 12, 1984
- Product Code
- HKM
- 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 |
|---|---|---|---|
| HKM | Retinoscope, Battery-Powered | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HKM), ordered by most recent decision date.
RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT
FDA 510(k)
FDA Class 1
·Ophthalmic
STREAK RETINOSCOPE RX-3A
FDA 510(k)
FDA Class 1
·Ophthalmic
SPOT RETINOSCOPE RX-3SP
FDA 510(k)
FDA Class 1
·Ophthalmic
STREAK RETINOSCOPE RX-RC
FDA 510(k)
FDA Class 1
·Ophthalmic
STREAK RETINOSCOPE RX-RP
FDA 510(k)
FDA Class 1
·Ophthalmic
STREAK RETINOSCOPE RX-3
FDA 510(k)
FDA Class 1
·Ophthalmic