KMG · Purifier, Water, Ultraviolet, Medical
General Hospital · 21 CFR 880.6710 · Class 2
Overview
| Product Code | KMG |
|---|---|
| Device Name | Purifier, Water, Ultraviolet, Medical |
| Regulation | 21 CFR 880.6710 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A medical ultraviolet water purifier is a device intended for medical purposes that is used to destroy bacteria in water by exposure to ultraviolet radiation.
Classification Rationale
Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in § 880.9.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K012029 | REMEDY MODEL 2Z12 | Apollo Corp. | Dec 31, 2001 | SESE |
| K832288 | HEMOGLOBINOMETER | Mallinckrodt Critical Care | Sep 1, 1983 | SESE |
| K831253 | LANCER HEMOGLOBIN ANALYZER REAGENTS | Sherwood Medical Co. | May 9, 1983 | SESE |
| K813050 | AQUANOMICS, #MP4SF | Cooper-Hewitt Electric Co. | Dec 2, 1981 | SESE |
| K813049 | AQUANOMICS, #HHU100 | Cooper-Hewitt Electric Co. | Dec 2, 1981 | SESE |
| K813048 | AQUANOMICS, #MP2SF | Cooper-Hewitt Electric Co. | Dec 2, 1981 | SESE |
| K813047 | AQUANOMICS, MINI 60L | Cooper-Hewitt Electric Co. | Dec 2, 1981 | SESE |
| K813046 | AQUANOMICS, #HHU60 | Cooper-Hewitt Electric Co. | Dec 2, 1981 | SESE |
| K813045 | AQUANOMICS, #SP36SF | Cooper-Hewitt Electric Co. | Dec 2, 1981 | SESE |
Top Applicants
- Cooper-Hewitt Electric Co. — 6 clearances
- Apollo Corp. — 1 clearance
- Mallinckrodt Critical Care — 1 clearance
- Sherwood Medical Co. — 1 clearance
