FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
'E' CUBE AND 'E' PAD
K Number: K873916
·
Decision Dec 11, 1987
Classifications
1
FEI Numbers
106
Registration Numbers
107
Same Product Code
31
Applicant Total
15
Review Days
77
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Basic Information
- Device Name
- 'E' CUBE AND 'E' PAD
- K Number
- K873916
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Richmond Products, Inc.
- Date Received
- September 25, 1987
- Decision Date
- December 11, 1987
- Product Code
- HOX
- 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 |
|---|---|---|---|
| HOX | Chart, Visual Acuity | FDA class 1 | Ophthalmic |
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Other Clearances by Richmond Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874252 | KREDA DISC | Jan 27, 1988 | Substantially Equivalent |
| K874250 | THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT. | Jan 11, 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 |
| 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 |