FDA Product Code
FDA Product Code FIP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5665
510(k) Clearances — 117 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K945136 | RENAGUARD DIALYSATE FILTER | Minntech Corp. | 1995-02-28 | Traditional | PDF ↗ |
| K931595 | REVERSE OSMOSIS EQUIPMENT FOR WATER PURIFICATION | Osmonics, Inc. | 1994-12-29 | Traditional | PDF ↗ |
| K934848 | MASTER ALERT | Master Hydro Systems, Inc. | 1994-09-29 | Traditional | PDF ↗ |
| K915258 | SERVICE DEIONIZATION SYST/DI TANK EXCHANGE PROGRAM | Aqua-Med Systems, Inc. | 1993-07-02 | Traditional | PDF ↗ |
| K894300 | SUBMERSIBLE REVERSE OSMOSIS WATER PURIFICATION SYS | U.S. Filter/Continental Water Systems | 1990-03-13 | Traditional | PDF ↗ |
| K894106 | DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST | Cd Medical, Inc. | 1989-11-08 | Traditional | PDF ↗ |
| K871242 | REVERSE OSMOSIS WATER PURIFICATION SYSTEM | Medro Systems, Inc. | 1988-03-16 | Traditional | PDF ↗ |
| K873487 | HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES | Water Pure, Inc. | 1987-10-23 | Traditional | PDF ↗ |
| K863720 | HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES | Water Pure, Inc. | 1986-10-29 | Traditional | PDF ↗ |
| K842215 | ASCORBIC ACID | Organon Teknika Corp. | 1984-08-02 | Traditional | PDF ↗ |
| K841403 | HEMO-RO WATER PURIFICATION SYS | Millipore Corp. | 1984-07-06 | Traditional | PDF ↗ |
| K822385 | EXTRAPURE REVERSE OSMOSIS WATER UNIT | Extracorporeal Medical Specialities, Inc. | 1982-10-13 | Traditional | PDF ↗ |
| K811678 | GAMBRO WATER PURIFICATION MONITOR WRD | Gambro, Inc. | 1981-07-10 | Traditional | PDF ↗ |
| K802474 | CMR 300, ROWATER TREATMENT UNIT | U-Marc, Inc. | 1980-12-15 | Traditional | PDF ↗ |
| K800305 | WATER CONDUCTIVITY MONITOR & CONTROLLER | Darco Water Systems, Inc. | 1980-04-08 | Traditional | PDF ↗ |
| K791086 | CENTRY 2 SYSTEM #016, 103, 016, 104 | Cobe Laboratories, Inc. | 1979-07-03 | Traditional | PDF ↗ |
| K771763 | HEMO-RO | Millipore Corp. | 1977-10-04 | Traditional | PDF ↗ |
Product code FIP · Class II · Gastroenterology, Urology. Data: openFDA.