FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORC ORACLE
K Number: K853668
·
Decision Oct 15, 1985
Classifications
1
FEI Numbers
17
Registration Numbers
18
Same Product Code
28
Applicant Total
3
Review Days
42
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Basic Information
- Device Name
- ORC ORACLE
- K Number
- K853668
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Optical Radiation Corp.
- Date Received
- September 3, 1985
- Decision Date
- October 15, 1985
- Product Code
- HLQ
- 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 |
|---|---|---|---|
| HLQ | Keratoscope, Ac-Powered | FDA class 1 | Ophthalmic |
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