Waters Assoc., Inc.
Mchenry, IL, US
Waters Assoc., Inc. appears in FDA device records in Mchenry, IL. FDA records list 16 510(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
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Waters Assoc., Inc. between 1976 and 1981. The busiest year on record is 1979, with 6. The most recent is 1981, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1978 | 5 |
| 1979 | 6 |
| 1980 | 3 |
| 1981 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K811975 | MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL | JJQ | Substantially Equivalent | |
| K802481 | 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH | DYG | Substantially Equivalent | |
| K801852 | MRM-2 OXYGEN CONSUMPTION MONITOR | BZL | Substantially Equivalent | |
| K801431 | PAN-AM MYELOGRAM TRAY | FMI | Substantially Equivalent | |
| K791661 | SYSTEM CONTROLLER 720 SERIES | KIE | Substantially Equivalent | |
| K791026 | 4F STERILE BALLOON-LESS, CATHETER 913-28 | KRB | Substantially Equivalent | |
| K790145 | SOLVENT DELIVERY SYSTEM | KIE | Substantially Equivalent | |
| K782175 | CARTRIDGE HOLDER, RCM 100 | KIE | Substantially Equivalent | |
| K781805 | CARDIAC COMPUTERS, CO-10 & CO-10R | DXG | Substantially Equivalent | |
| K781915 | DATA MODULE | KIE | Substantially Equivalent | |
| K781692 | CALIBRATOR, DYNAMIC | DXM | Substantially Equivalent | |
| K781264 | PAB CONVENIENCE TRAY | GAA | Substantially Equivalent | |
| K780245 | RECORDER, RE-100P HOT STYLUS STRIP CHART | DSF | Substantially Equivalent | |
| K780031 | FLUORESCENCE DETECTOR MODEL 420 | KHO | Substantially Equivalent | |
| K772311 | WISP MODEL 710 | CHH | Substantially Equivalent | |
| K761166 | TC-1 CARDIAC OUTPUT COMPUTER | DXG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KIEApparatus, High Pressure Liquid Chromatography
- DYGCatheter, Flow Directed
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- BZLComputer, Oxygen-Uptake
- DXMDensitometer
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- KHOFluorometer, For Clinical Use
- GAANeedle, Aspiration And Injection, Disposable
- FMINeedle, Hypodermic, Single Lumen
- KRBProbe, Thermodilution
- DSFRecorder, Paper Chart
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain