FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT.
K Number: K874250
·
Decision Jan 11, 1988
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
2
Applicant Total
15
Review Days
84
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Basic Information
- Device Name
- THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT.
- K Number
- K874250
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1880
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Richmond Products, Inc.
- Date Received
- October 19, 1987
- Decision Date
- January 11, 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.
VKG 1000, VIDEO KERATOMETER
FDA 510(k)
FDA Class 1
·Ophthalmic
WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Richmond Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874252 | KREDA DISC | Jan 27, 1988 | Substantially Equivalent |
| K874251 | WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT | Jan 11, 1988 | Substantially Equivalent |
| K873907 | CONFIRMATION TESTS | Dec 29, 1987 | Substantially Equivalent |
| K873908 | H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. | Dec 23, 1987 | Substantially Equivalent |
| K873916 | 'E' CUBE AND 'E' PAD | Dec 11, 1987 | Substantially Equivalent |
| K873914 | ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT) | Dec 11, 1987 | Substantially Equivalent |
| K873913 | COLOR BOOK ILLUMINATOR STAND | Dec 2, 1987 | Substantially Equivalent |
| K873911 | PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 | Dec 2, 1987 | Substantially Equivalent |
| K873917 | TONOMETER TAPES | Nov 2, 1987 | Substantially Equivalent |
| K873912 | RICHMOND VISUAL FIELD SCREENER | Nov 2, 1987 | Substantially Equivalent |