510(k) K810021
K810021 is an FDA 510(k) premarket notification submitted by Laminar Flow Industries for the device "FLO-TEMP". The FDA issued a decision of Substantially Equivalent on January 23, 1981. The device falls under product code FLA (Monitor, Temperature, Dialysis), a Class II device regulated under 21 CFR 876.5820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 1981
- Date Received
- January 5, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Temperature, Dialysis
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type