Waters Instruments, Inc.
Plymouth, MN, US
Waters Instruments, Inc. appears in FDA device records in Plymouth, MN. FDA records list 12 510(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
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Waters Instruments, Inc. between 1981 and 2006. The busiest year on record is 1984, with 2. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1982 | 1 |
| 1984 | 2 |
| 1985 | 1 |
| 1986 | 2 |
| 1991 | 1 |
| 1992 | 1 |
| 1997 | 1 |
| 2004 | 1 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K053169 | RM3 RENAL PRESERVATION SYSTEM | KDK | Substantially Equivalent | |
| K042224 | RM3 RENAL PRESERVATION SYSTEM | KDN | Substantially Equivalent | |
| K971571 | RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT | KDN | Substantially Equivalent | |
| K921519 | OXICOM-2100 | DQA | Substantially Equivalent | |
| K911207 | OXICOMPLUS | DQA | Substantially Equivalent | |
| K863210 | VELCOM-100 | DPW | Substantially Equivalent | |
| K862161 | OSC-80 OXIMETER | DQA | Substantially Equivalent | |
| K852909 | MVP - 6000 | BZC | Substantially Equivalent | |
| K834408 | TX-2 THERMAL DILUTION CARDIAC OUTPUT | DXG | Substantially Equivalent | |
| K841876 | POLYURETHANE THERMAL DILUTION CATHET | DYG | Substantially Equivalent | |
| K813585 | WATERS ILEOSTOMY VALVE | KNT | Substantially Equivalent | |
| K813494 | WATERS ILEAL RESERVOIR CATHETER | KPH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- BZCCalculator, Pulmonary Function Data
- DYGCatheter, Flow Directed
- KPHCatheter, Rectal For Continent Ileostomy
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- KDKContainer, Transport, Kidney
- DPWFlowmeter, Blood, Cardiovascular
- DQAOximeter
- KDNSystem, Perfusion, Kidney
- KNTTubes, Gastrointestinal (And Accessories)
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