510(k) K911383
K911383 is an FDA 510(k) premarket notification submitted by Level 1 Technologies, Inc. for the device "HOTLINE FLUID WARMER". The FDA issued a decision of Substantially Equivalent on October 17, 1991. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725. Level 1 Technologies, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 1991
- Date Received
- March 28, 1991
- 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