510(k) K813489
K813489 is an FDA 510(k) premarket notification submitted by Cryosan, Inc. for the device "ROCKING/CIRCULATING CYTO-THERM II 3570". The FDA issued a decision of Substantially Equivalent on March 4, 1982. The device falls under product code KZL (Device, Warming. Blood And Plasma), a Class II device regulated under 21 CFR 864.9205. Cryosan, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 1982
- Date Received
- December 1, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Warming. Blood And Plasma
- Device Class
- Class II
- Regulation Number
- 864.9205
- Review Panel
- HE
- Submission Type