510(k) K192325
K192325 is an FDA 510(k) premarket notification submitted by Life Warmer, Inc. for the device "Quantum Blood and Fluid Warming System". The FDA issued a decision of Substantially Equivalent on October 18, 2019. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725. Life Warmer, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2019
- Date Received
- August 27, 2019
- Clearance Type
- Special
- 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