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510(k) K991160

ASTOTHERM PLUS, ASTOTUBES, ASTOLINE by Stihler Electronic GmbH — Product Code BSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1999
Date Received
April 7, 1999
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Blood, Non-Electromagnetic Radiation
Device Class
Class II
Regulation Number
864.9205
Review Panel
HE
Submission Type

Other clearances by Stihler Electronic GmbH

  • K202197 — Astopad Patient Warming System (September 4, 2020)
  • K082758 — PRISMAFLO II (December 19, 2008)
  • K082765 — ASTOFLO PLUS (December 18, 2008)
  • K020103 — PRISMAFLO (July 24, 2002)
  • K991159 — PRISMATHERM II, ASTOLINE (September 3, 1999)

Other clearances for product code BSB

  • K112639 — THE BELMONT BUDDY LITE FLUID WARMER (November 16, 2011)
  • K090508 — THE BELMONT BUDDY LITE FLUID WARMER (March 26, 2009)
  • K062774 — BELMONT BUDDY PLUS FLUID WARMER (October 19, 2006)
  • K052547 — BELMONT BUDDY FLUID WARMER (October 13, 2005)
  • K031478 — MICROHEATER (July 2, 2003)
  • K020060 — ASTOFLO (March 5, 2002)
  • K012031 — MODIFICATION TO THERMAL ANGEL (July 26, 2001)
  • K991159 — PRISMATHERM II, ASTOLINE (September 3, 1999)
  • K984640 — THERMAL ANGEL (July 1, 1999)
  • K973741 — BAIR HUGGER BLOOD/FLUID WARMER (April 30, 1998)