Home / 510(k) Clearances / K082765

510(k) K082765

ASTOFLO PLUS by Stihler Electronic GmbH — Product Code LGZ

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

Other clearances by Stihler Electronic GmbH

  • K202197 — Astopad Patient Warming System (September 4, 2020)
  • K082758 — PRISMAFLO II (December 19, 2008)
  • K020103 — PRISMAFLO (July 24, 2002)
  • K991159 — PRISMATHERM II, ASTOLINE (September 3, 1999)
  • K991160 — ASTOTHERM PLUS, ASTOTUBES, ASTOLINE (September 2, 1999)

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)