510(k) K813327
K813327 is an FDA 510(k) premarket notification submitted by Separation Science Corp. for the device "SEPCOR TEMPERATURE MONITOR". The FDA issued a decision of Substantially Equivalent on December 31, 1981. The device falls under product code KSE (Refrigerator, Freezer, Blood Storage), a Class II device regulated under 21 CFR 864.9700. Separation Science Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 1981
- Date Received
- November 24, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Refrigerator, Freezer, Blood Storage
- Device Class
- Class II
- Regulation Number
- 864.9700
- Review Panel
- HE
- Submission Type