FDA 510(k)
FDA class 1
Substantially Equivalent
🇯🇵 Japan
STREAK RETINOSCOPE RX-RC
K Number: K950794
·
Decision Mar 28, 1995
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
6
Applicant Total
24
Review Days
35
Basic Information
- Device Name
- STREAK RETINOSCOPE RX-RC
- K Number
- K950794
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1780
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- NEITZ INSTRUMENTS COMPANY, LTD.
- Date Received
- February 21, 1995
- Decision Date
- March 28, 1995
- 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-3
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-RP
FDA 510(k)
FDA Class 1
·Ophthalmic
GENERATED RETINAL REFLEX IMAGERY SYS
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by NEITZ INSTRUMENTS COMPANY, LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K972440 | CATARACTSCREENER CT - S | Sep 30, 1997 | Substantially Equivalent |
| K951341 | NEITZ SLIT LAMP SL-H2 | Jun 15, 1995 | Substantially Equivalent |
| K951337 | FIBER HEAD LIGHT FH-300 | Jun 8, 1995 | Substantially Equivalent |
| K950788 | OTOSCOPE A-34 | May 3, 1995 | Substantially Equivalent |
| K951340 | NEITZ SLIT LAMP SL-H1 | Apr 10, 1995 | Substantially Equivalent |
| K951338 | INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV | Apr 7, 1995 | Substantially Equivalent |
| K950789 | STREAK RETINOSCOPE RX-1 | Mar 28, 1995 | Substantially Equivalent |
| K950797 | HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134 | Mar 28, 1995 | Substantially Equivalent |
| K950791 | STREAK RETINOSCOPE RX-3 | Mar 28, 1995 | Substantially Equivalent |
| K950792 | STREAK RETINOSCOPE RX-3A | Mar 28, 1995 | Substantially Equivalent |