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510(k) K991159

PRISMATHERM II, ASTOLINE by Stihler Electronic GmbH — Product Code BSB

K991159 is an FDA 510(k) premarket notification submitted by Stihler Electronic GmbH for the device "PRISMATHERM II, ASTOLINE". The FDA issued a decision of Substantially Equivalent on September 3, 1999. The device falls under product code BSB (Warmer, Blood, Non-Electromagnetic Radiation), a Class II device regulated under 21 CFR 864.9205. Stihler Electronic GmbH has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 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

  • K260278 — ThermAffyx(TM) Patient Safety System (July 8, 2026)
  • 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)
  • K991160 — ASTOTHERM PLUS, ASTOTUBES, ASTOLINE (September 2, 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)
  • K991160 — ASTOTHERM PLUS, ASTOTUBES, ASTOLINE (September 2, 1999)
  • K984640 — THERMAL ANGEL (July 1, 1999)
  • K973741 — BAIR HUGGER BLOOD/FLUID WARMER (April 30, 1998)

FDA data resources