FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RELIANCE OPHTHALMIC SLIT LAMP R-083
K Number: K834060
·
Decision Feb 4, 1984
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
9
Review Days
71
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Basic Information
- Device Name
- RELIANCE OPHTHALMIC SLIT LAMP R-083
- K Number
- K834060
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- F. & F. Koenigkramer
- Date Received
- November 25, 1983
- Decision Date
- February 4, 1984
- Product Code
- HQF
- 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 |
|---|---|---|---|
| HQF | Laser, Ophthalmic | FDA class 2 | Ophthalmic |
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| K Number | Device Name | ||
|---|---|---|---|
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| K853150 | RELIANCE 6100 | Sep 5, 1985 | Substantially Equivalent |
| K853151 | RELIANCE 5000 | Sep 5, 1985 | Substantially Equivalent |
| K843046 | RELIANCE TREATMENT CABINET | Sep 27, 1984 | Substantially Equivalent |
| K831568 | RELIANCE TEMPO OPHTH. INSTR STAND | Jun 30, 1983 | Substantially Equivalent |
| K812544 | RELIANCE OPHTHALMIC INSTRUMENT CONTROL | Sep 21, 1981 | Substantially Equivalent |
| K761147 | RELIANCE MOD-U-LINE M-700 | Jan 28, 1977 | Substantially Equivalent |