REMEDY MODEL 2Z12
FDA 510(k) clearance K012029 · decided 2001-12-31
Clearance details
- K-number
- K012029
- Device name
- REMEDY MODEL 2Z12
- Applicant
- Apollo Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-06-28
- Decision date
- 2001-12-31
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- KMG
- Device class
- 2
- Regulation number
- 880.6710
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Somerset, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HEMOGLOBINOMETER (K832288) | Mallinckrodt Critical Care | 1983-09-01 |
| LANCER HEMOGLOBIN ANALYZER REAGENTS (K831253) | Sherwood Medical Co. | 1983-05-09 |
| AQUANOMICS, #HHU100 (K813049) | Cooper-Hewitt Electric Co. | 1981-12-02 |
| AQUANOMICS, #SP36SF (K813045) | Cooper-Hewitt Electric Co. | 1981-12-02 |
| AQUANOMICS, #MP2SF (K813048) | Cooper-Hewitt Electric Co. | 1981-12-02 |
| AQUANOMICS, #MP4SF (K813050) | Cooper-Hewitt Electric Co. | 1981-12-02 |
| AQUANOMICS, MINI 60L (K813047) | Cooper-Hewitt Electric Co. | 1981-12-02 |
| AQUANOMICS, #HHU60 (K813046) | Cooper-Hewitt Electric Co. | 1981-12-02 |
Recalls involving this device
No recalls on record reference this clearance.