Home / 510(k) Clearances / K914364

510(k) K914364

ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO. by North American Technical Services Corp. — Product Code LGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1992
Date Received
October 1, 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

Other clearances by North American Technical Services Corp.

  • K974321 — HYDROTONE (June 22, 1998)
  • K970592 — N/A (June 13, 1997)
  • K970590 — N/A (June 13, 1997)
  • K961582 — EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 (November 8, 1996)
  • K953440 — ELLMAN LAPTRODE (August 29, 1995)
  • K944558 — ELLMAN VAPOR-VAC II (April 28, 1995)
  • K944730 — MASSAGER (February 14, 1995)
  • K932204 — E-Z THERM 3 SECOND THERMOMETER (October 3, 1994)

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)