American Optical Corp.
Mchenry, IL, US
American Optical Corp. appears in FDA device records in Mchenry, IL. FDA records list 35 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 35
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 35 510(k) clearances for American Optical Corp. between 1976 and 1995. The busiest year on record is 1979, with 8. The most recent is 1995, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 2 |
| 1978 | 4 |
| 1979 | 8 |
| 1980 | 6 |
| 1981 | 8 |
| 1982 | 1 |
| 1994 | 3 |
| 1995 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K950881 | PHACO TIP | HQC | Substantially Equivalent | |
| K950880 | AOI UNIVERSAL ULTRASONIC HANDPIECE | HQC | Substantially Equivalent | |
| K931358 | AORP4000 REUSABLE PAK | HQC | Substantially Equivalent | |
| K931354 | P4000 PHACOEMULSIFIER | HQC | Substantially Equivalent | |
| K931357 | AOD4000 DISPOSABLE PAK | HQC | Substantially Equivalent | |
| K820790 | FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 | FAM | Substantially Equivalent | |
| K813430 | TISSUE PROCESSING CASSETTES & ACCESS | IDL | Substantially Equivalent | |
| K812965 | MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE | FAM | Substantially Equivalent | |
| K812051 | PHOTOLITE AOLITE TINTOMATIC LENS | HQG | Substantially Equivalent | |
| K812063 | SR-1V DATA PRINTER | HKO | Substantially Equivalent | |
| K811535 | MODEL FUS-1, FLEXIBLE URETEROSCOPE | FGB | Substantially Equivalent | |
| K811180 | ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ | HOS | Substantially Equivalent | |
| K811181 | MODEL FBS-1, FLEXIBLE BRONCHOSCOPE | EOQ | Substantially Equivalent | |
| K802183 | SR-IV PROGRAMMED SUBJECTIVE REFRACTOR | HKO | Substantially Equivalent | |
| K802419 | AO NON-CONTACT II TONOMETER | HKX | Substantially Equivalent | |
| K802331 | AO FLEXIBLE LARYNGOSCOPE, #LS-7 | CAL | Substantially Equivalent | |
| K801638 | A O CUSTOM II CHAIR AND STAND | HME | Substantially Equivalent | |
| K801364 | AO STYLET LARYNGOSCOPE MODEL SLS | CAL | Substantially Equivalent | |
| K801110 | PRESSURE MONITOR, MODEL 1131B | DSK | Substantially Equivalent | |
| K800192 | DURALITE LENS | HPX | Substantially Equivalent | |
| K792179 | AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE | FDF | Substantially Equivalent | |
| K792081 | SPECTRA CENTRAL PT MONITORING SYS | DSI | Substantially Equivalent | |
| K791721 | ULTRAVUE BLENDED BIFOCAL LENS | HQG | Substantially Equivalent | |
| K791635 | AO TEACHING ATTACHMENT, MODEL TA-1 | FEA | Substantially Equivalent | |
| K791634 | AO STYLET LARYNGOSCOPE, MODEL SLS-1 | CAL | Substantially Equivalent | |
| K790338 | COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER | FDF | Substantially Equivalent | |
| K790251 | FUL-VUE ASPHERIC CATARACT LENS | HQG | Substantially Equivalent | |
| K782118 | FUL-VUE | HKN | Substantially Equivalent | |
| K781845 | CAMSCAN SYSTEM | DSI | Substantially Equivalent | |
| K781241 | UNISTAT BILIRUBINOMETER | JJQ | Substantially Equivalent | |
| K780625 | UNISTAT OXIMETER | DQA | Substantially Equivalent | |
| K780343 | ARRHYTHMIA TREND ENHANCEMENT | DSI | Substantially Equivalent | |
| K771914 | SUBJECTIVE REFRACTOR, MOSEL SR-111 | HKO | Substantially Equivalent | |
| K770221 | MEMLITE (PLASTIC EYEGLASS FRAMES) | HQZ | Substantially Equivalent | |
| K761163 | AD7 PLASTIC MULTIFOCAL EYEGLASS LENS | HQG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FEAAttachment, Teaching, For Endoscope
- EOQBronchoscope (Flexible Or Rigid)
- HMEChair, Ophthalmic, Ac-Powered
- FDFColonoscope And Accessories, Flexible/Rigid
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- DSKComputer, Blood-Pressure
- DSIDetector And Alarm, Arrhythmia
- HQZFrame, Spectacle
- CALLaryngoscope, Non-Rigid
- HPXLens, Contact (Polymethylmethacrylate)
- HQGLens, Spectacle, Non-Custom (Prescription)
- IDLMicrotome, Accessories
- DQAOximeter
- HOSProjector, Ophthalmic
- HKORefractometer, Ophthalmic
- HKNRefractor, Manual, Non-Powered, Including Phoropter
- FAMSigmoidoscope And Accessories, Flexible/Rigid
- HKXTonometer, Ac-Powered
- HQCUnit, Phacofragmentation
- FGBUreteroscope And Accessories, Flexible/Rigid
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
