KZL — Device, Warming. Blood And Plasma Class II
FDA product code KZL covers "Device, Warming. Blood And Plasma", a Class II medical device regulated under 21 CFR 864.9205. Submissions are reviewed by the Hematology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KZL
- Device Class
- Class II
- Regulation Number
- 864.9205
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K813489 | cryosan | ROCKING/CIRCULATING CYTO-THERM II 3570 | March 4, 1982 |
| K812311 | cryosan | CIRCULATING CYTO-THERMS | September 16, 1981 |
| K800699 | chroma products | FLO TEM (FLUID WARNER) | May 8, 1980 |
| K790936 | vickers america medical | MODEL 114 TREONIC H150 HAEMOHEATER | September 4, 1979 |