Home / 510(k) Clearances / K012276

510(k) K012276

TEMP 3 by Medical Solutions, Inc. — Product Code LGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2001
Date Received
July 19, 2001
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

Other clearances by Medical Solutions, Inc.

  • K093689 — 1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS (August 31, 2010)
  • K041839 — 8NONE (February 15, 2005)
  • K981032 — PIV SYSTEM (September 2, 1998)
  • K980086 — HEAT STACK (March 10, 1998)

Other clearances for product code LGZ

  • K252636 — Fluido Compact System (November 18, 2025)
  • K251733 — Fluido® AirGuard System (September 4, 2025)
  • K232107 — °M Warmer System (May 31, 2024)
  • K211618 — Fluido Compact Blood and Fluid Warming System (June 5, 2023)
  • K211800 — Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior (December 8, 2022)
  • K202461 — ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion Sys (August 12, 2022)
  • K213191 — S-Line (May 24, 2022)
  • K192325 — Quantum Blood and Fluid Warming System (October 18, 2019)
  • K180842 — MAC Medical D-Series Blanket and Solution Warming Cabinets (March 5, 2019)
  • K181775 — Quantum Blood and IV Fluid Infusion Warmer (January 28, 2019)