FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SR-1V DATA PRINTER
K Number: K812063
·
Decision Aug 18, 1981
Classifications
1
FEI Numbers
74
Registration Numbers
75
Same Product Code
34
Applicant Total
35
Review Days
28
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Basic Information
- Device Name
- SR-1V DATA PRINTER
- K Number
- K812063
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1760
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- American Optical Corp.
- Date Received
- July 21, 1981
- Decision Date
- August 18, 1981
- 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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| K931357 | AOD4000 DISPOSABLE PAK | Jan 25, 1994 | Substantially Equivalent |
| K820790 | FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 | Apr 1, 1982 | Substantially Equivalent |
| K813430 | TISSUE PROCESSING CASSETTES & ACCESS | Dec 29, 1981 | Substantially Equivalent |
| K812965 | MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE | Nov 2, 1981 | Substantially Equivalent |
| K812051 | PHOTOLITE AOLITE TINTOMATIC LENS | Sep 8, 1981 | Substantially Equivalent |
| K811535 | MODEL FUS-1, FLEXIBLE URETEROSCOPE | Jun 23, 1981 | Substantially Equivalent |