510(k) K012029
- Device
- REMEDY MODEL 2Z12
- Applicant
- APOLLO CORP.
- 510(k) number
- K012029
- Product code
- KMG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-12-31
- Date received
- 2001-06-28
- Regulation
- 880.6710
- Classification name
- Purifier, Water, Ultraviolet, Medical
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ADRIAN SWEEN
- Address
- 450 Main St. Somerset WI US 54025 54025
FDA Registration Numbers#
- 2028411
- 3027509245
- 3014150341
- 3017125427
Source Documents#
Other 510(k) Records For Product Code KMG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K832288 | HEMOGLOBINOMETER | Mallinckrodt Critical Care | 1983-09-01 |
| K831253 | LANCER HEMOGLOBIN ANALYZER REAGENTS | Sherwood Medical Co. | 1983-05-09 |
| K813045 | AQUANOMICS, #SP36SF | Cooper-Hewitt Electric Co. | 1981-12-02 |
| K813046 | AQUANOMICS, #HHU60 | Cooper-Hewitt Electric Co. | 1981-12-02 |
| K813047 | AQUANOMICS, MINI 60L | Cooper-Hewitt Electric Co. | 1981-12-02 |
| K813048 | AQUANOMICS, #MP2SF | Cooper-Hewitt Electric Co. | 1981-12-02 |
| K813049 | AQUANOMICS, #HHU100 | Cooper-Hewitt Electric Co. | 1981-12-02 |
| K813050 | AQUANOMICS, #MP4SF | Cooper-Hewitt Electric Co. | 1981-12-02 |
Legacy Summary#
summary
FDA Review#
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