FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EYE CHARTS
K Number: K813376
·
Decision Jan 7, 1982
Classifications
1
FEI Numbers
106
Registration Numbers
107
Same Product Code
31
Applicant Total
127
Review Days
37
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Basic Information
- Device Name
- EYE CHARTS
- K Number
- K813376
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Abco Dealers, Inc.
- Date Received
- December 1, 1981
- Decision Date
- January 7, 1982
- 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 Abco Dealers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905025 | DIGITAL THERMOMETER KITS | Feb 7, 1991 | Substantially Equivalent |
| K882304 | DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL) | Jul 12, 1988 | Substantially Equivalent |
| K880892 | BLOOD COLLECTING NEEDLE AND HOLDERS | Apr 21, 1988 | Substantially Equivalent |
| K880894 | ALLERGIST SYRINGES | Mar 31, 1988 | Substantially Equivalent |
| K872875 | STRETCH GAUZE BANDAGES | Sep 4, 1987 | Substantially Equivalent |
| K872874 | MICROSCOPE COVER GLASSES | Aug 10, 1987 | Substantially Equivalent |
| K872797 | NON-SKID SHOE COVERS | Aug 4, 1987 | Substantially Equivalent |
| K871465 | THERMOMETER SHEATHS | May 11, 1987 | Substantially Equivalent |
| K862726 | DISPOSABLE SHOE COVERS AND NURSES CAPS | Aug 1, 1986 | Substantially Equivalent |
| K862111 | ARMBOARDS, REUSABLE AND DISPOSABLE | Jul 8, 1986 | Substantially Equivalent |