510(k) K082765
K082765 is an FDA 510(k) premarket notification submitted by Stihler Electronic GmbH for the device "ASTOFLO PLUS". The FDA issued a decision of Substantially Equivalent on December 18, 2008. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725. Stihler Electronic GmbH has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2008
- Date Received
- September 22, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Warmer, Thermal, Infusion Fluid
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type