510(k) K800699
K800699 is an FDA 510(k) premarket notification submitted by Chroma Products, Inc. for the device "FLO TEM (FLUID WARNER)". The FDA issued a decision of Substantially Equivalent on May 8, 1980. The device falls under product code KZL (Device, Warming. Blood And Plasma), a Class II device regulated under 21 CFR 864.9205.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 1980
- Date Received
- March 28, 1980
- 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