FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8
K Number: K924778
·
Decision Apr 5, 1993
Classifications
1
FEI Numbers
74
Registration Numbers
75
Same Product Code
34
Applicant Total
19
Review Days
194
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Basic Information
- Device Name
- BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8
- K Number
- K924778
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1760
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- R.H. Burton Co.
- Date Received
- September 23, 1992
- Decision Date
- April 5, 1993
- Product Code
- HKO
- 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 |
|---|---|---|---|
| HKO | Refractometer, Ophthalmic | FDA class 1 | Ophthalmic |
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| K Number | Device Name | ||
|---|---|---|---|
| K924773 | BURTON H- BASE TABLE - MODEL 1990 | Jun 7, 1993 | Substantially Equivalent |
| K924783 | BURTON SLIT LAMP - MODEL 850 | Apr 14, 1993 | Substantially Equivalent |
| K924774 | BURTON AUTOMATIC PROJECTOR - MODEL CP-40 | Apr 14, 1993 | Substantially Equivalent |
| K924786 | BURTON TRIAL LENS SET | Apr 14, 1993 | Substantially Equivalent |
| K924776 | BURTON LENSMETER - MODEL 2021 | Apr 5, 1993 | Substantially Equivalent |
| K924780 | BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 | Apr 5, 1993 | Substantially Equivalent |
| K924779 | BURTON KERATOMETER - MODLE 2040 | Apr 5, 1993 | Substantially Equivalent |
| K924788 | BURTON LENSMETER | Apr 5, 1993 | Substantially Equivalent |
| K924785 | BURTON RADIUSGAUGE - MODEL 2030 | Apr 5, 1993 | Substantially Equivalent |
| K924790 | BURTON AUTO REFRACTOR - MODEL BAR-7 | Apr 5, 1993 | Substantially Equivalent |