SEPCOR TEMPERATURE MONITOR
Device Facts
| Record ID | K813327 |
|---|---|
| Device Name | SEPCOR TEMPERATURE MONITOR |
| Applicant | Separation Science Corp. |
| Product Code | KSE · Hematology |
| Decision Date | Dec 31, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.9700 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A blood storage refrigerator and a blood storage freezer are devices intended for medical purposes that are used to preserve blood and blood products by storing them at cold or freezing temperatures.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
